Method of treating diseases using an IL-17 receptor antibody formulation
Granted 22 Nov 2022 · 2 office actions
Assignee: Kirin-Amgen, Inc.
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Inventors: David Andrew Martin, Christopher Boyd Russell, Christopher Endres, Dingjiang Liu +3 · Examiner: Dong Jiang · AU 1646 · TC 1600
Life of the patent
13 dated eventsAbstract
The present disclosure relates to AM-14 pharmaceutical formulations and therapeutic dosing regimens for the treatment of disease.
Description
79 parts›CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of copending U.S. application Ser. No. 16/053,564, filed Aug. 2, 2018, which is a continuation of U.S. application Ser. No. 14/499,691, filed Sep. 29, 2014, now U.S. Pat. No. 10,072,085, which is a divisional of U.S. application Ser. No. 13/521,999, filed Jul. 12, 2012, now U.S. Pat. No. 8,883,151, which is a national phase application under 35 U.S.C. § 371 of PCT International Application No. PCT/US2011/020985, filed Jan. 12, 2011, which claims the benefit under 35 U.S.C. 119(e) of U.S. patent application No. 61/295,387, filed Jan. 15, 2010 and U.S. patent application No. 61/422,059, filed Dec. 10, 2010, which are incorporated herein by reference.
›INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ELECTRONICALLY
Incorporated by reference in its entirety herein is a computer-readable nucleotide/amino acid sequence listing submitted concurrently herewith and identified as follows: One 13,202 Byte ASCII (Text) file named “36253-306-SQL_ST25.TXT,” created on Sep. 8, 2020.
›BACKGROUND
Interleukin-17 (IL-17A) is an inflammatory cytokine initially identified as a transcript selectively expressed by activated T cells. IL-17A and IL-17F bind and activate IL-17RA. IL-17RA has been shown to be important in regulating immune responses. Activation of the IL-17RA leads to production of cytokines, chemokines, growth factors, and other proteins that contribute to the symptoms and/or pathology of numerous diseases. IL-17A is an inflammatory cytokine that induces the production of cytokines and other mediators leading to diseases and physiological effects such as inflammation, cartilage degradation, and bone resorption. IL-17A may play a role in a number of inflammatory conditions including arthritis (rheumatoid arthritis), psoriasis, inflammatory bowel disease, multiple sclerosis, and asthma. (Li et al., 2004 , Huazhong Univ. Sci. Technolog. Med. Sci. 24:294-296; Fujino et al., 2003 , Gut. 52:65-70; Kauffman et al., 2004 , J. Invest. Dermatol. 123:1037-1044; Mannon et al., 2004 , N. Engl. J Med. 351:2069-2079; Matusevicius et al., 1999 , Mult Scler 5, 101-104; Linden et al., Eur Respir J. 2000 May; 15(5):973-7; Molet et al., 2001 , J. Allergy Clin. Immunol. 108:430-438). Recent studies have suggested that IL-17F plays a role in the induction of inflammatory responses (Oda et al., 2006 , American J. Resp. Crit. Care Medicine , Jan. 15, 2006; Numasaki et al., 2004 , Immunol Lett. 95:97-104).
IL-17 Receptor A (IL-17RA) has been shown to bind and be activated by IL-17A and IL-17F. Five additional IL-17-like ligands (IL-17B-IL-17F) and four additional IL-17RA-like receptors (IL-17RB-IL-17RE) have been identified (Kolls and Linden, 2004 , Immunity 21:467-476; Gaffen, 2009 , Nat Rev Immunol 8:556-568). IL-17 Receptor C (IL-17RC) has been shown to bind and be activated by IL-17A and IL-17F. IL-17RA and IL-17RC form a functional heteromeric receptor complex (Toy et al., 2006 , J. Immunol. 177:36-39; McAllister et al., 2005 , J. Immunol. 175:404-412). In addition, IL-17 Receptor B (IL-17RB) has also been shown to require IL-17RA for IL-25 mediated activity (Rickel, et al., 2008 , J. Immunol. 181:4299-4310), and IL-17RD interacts with IL-17RA to mediate IL-17 signaling (Rong, et al., 2009 , Cell Research 19:208-215).
›DESCRIPTION OF THE DRAWINGS
FIG. 1 : A graph depicting the relationship between viscosity and shear rate for various AM-14 formulations. Various excipients were evaluated in a 10 mM glutamate, pH 4.5 buffer with AM-14 held constant at approximately 180 mg/ml.
FIG. 2 : A graph illustrating the relationship between viscosity and shear rate for various AM-14 formulations. Various excipients were evaluated in a 10 mM glutamate, pH 5.5 buffer with AM-14 held constant at approximately 180 mg/ml.
FIG. 3 : A graph depicting the viscosity of AM-14 at different protein concentrations.
FIG. 4 : A graph showing the relationship between the viscosity of an AM-14 formulation at 200 mg/ml as a function of varying pH.
FIG. 5 : A graph showing the mean percent IL-17 receptor occupancy as a function of time in healthy volunteers receiving AM-14 doses between 21 and 700 mg.
FIG. 6 : A graph showing the mean percent IL-17 receptor occupancy as a function of time in psoriasis patients receiving AM-14 doses of 140, 210 and 700 mg.
FIG. 7 : A graph showing the mean percent IL-17 receptor occupancy as a function of time in rheumatoid arthritis receiving AM-14 doses between 50 and 210 mg.
FIG. 8 : A graph showing monotonically increasing relationship between the pEC50 shift measured by the whole blood stimulation assay and the concentration of circulating AM-14 measured by the pharmacokinetic assay. The concentration of AM-14 is on the x-axis and the pEC50 shift is on the y-axis.
FIG. 9 : A graphical depiction of the predicted mean AM-14 pharmacokinetic profiles based on modeling of the single dose study
FIG. 10 : A schematic of the PK-PD model used in some forms of analysis. The syringe indicates sites of dosing: a bolus to the depot (SC); an infusion to the central compartment (IV); or initiation of a placebo effect. Inflammation (as measured by PASI score) is represented by an inflammation compartment with endogenous rates of synthesis (ksyn) and degradation (kdeg). Drug concentrations in the effect compartment act to decrease ksyn and thereby decreasing inflammation. The placebo effect is modeled as a hypothetical compartment with its own kinetics. The placebo effect acts to increase kdeg and thereby decreasing inflammation.
FIG. 11 : A depiction of the mean model-predicted PASI (as percent of baseline) compared to mean (SD) observed PASI data (as percent of baseline by cohort) over time after single dose administration of AM-14 or placebo.
FIG. 12 : A graphical depiction of the predicted mean PASI response time course for multiple dose scenarios (including placebo).
FIG. 13 : A graphical depiction of the predicted week 12 median percent PASI improvement (dose-response curve) for AM-14, with 90% confidence interval shaded; for various dose levels each administered SC at week 0, 1, 2, 4, 6, 8, and 10.
FIG. 14 : A graph depicting changes in epidermal thickness over time in subjects receiving AM-14 (filled object) compared to placebo (empty circles). Administration of AM-14 led to significant reductions in epidermal thickness in psoriasis subjects compared to placebo.
FIG. 15 : A graph depicting changes in Keratin-16 (KRT16) over time in subjects receiving AM-14 (filled object) compared to placebo (empty circles). Administration of AM-14 led to significant reductions in KRT16 mRNA in psoriasis subjects compared to placebo.
FIG. 16 : A graph depicting changes in Ki67 counts over time in subjects receiving AM-14 (filled object) compared to placebo (empty circles). AM-14 led to significant reductions in Ki67 counts in psoriasis subjects compared to placebo.
›DETAILED DESCRIPTION · 1 of 75
It is understood that any and all of the various attributes of the embodiments provided herein that are described in separate paragraphs and are later combined in a specific embodiment or the selection of a specific embodiment from a list of embodiments does not constitute added or new matter. Applicants affirmatively state that all such combinations are specifically envisioned and are specifically encompassed by this disclosure.
IL-17 Receptor “A”
“IL-17 receptor A” or “IL-17RA” (interchangeably used herein, as well as IL-17 receptor and IL-17R all refer to the same receptor) is the cell surface receptor known in the art (see for example Yao, et al., 1997 , Cytokine Vol. 9, No. 11:794-800). The cloning, characterization of IL-17RA is described, for example, in U.S. Pat. No. 6,072,033, which is incorporated herein by reference in its entirety. IL-17RA binds, at a minimum, IL-17A and/or IL-17F and is activated by IL-17A and/or IL-17F or other IL-17 ligands, as well as heteromeric forms of one or more IL-17 ligands, such as but not limited to, IL-17A/IL-17F heteromers.
IL-17RA Antibody Biopharmaceutical Formulations
Aspects of the present invention are directed to biopharmaceutical formulations (also referred to herein as simply “formulation”) incorporating the AM-14 antibody, as variously defined herein. AM-14 is described in detail in WO 2008/054603, U.S. Ser. No. 11/906,094, U.S. Pat. Nos. 7,786,234, 7,833,527, and 7,767,206 which are herein incorporated by reference in their entirety. AM-14 specifically binds to human IL-17RA and inhibits the biological activity of IL-17A, IL-17F, and IL-17A/IL-17F heterodimers, and/or the activation of IL-17RA as well as a heteromeric complex of IL-17RA and IL-17RC (IL-17 Receptor “C”). AM-14 also has the unique property of inhibiting IL-17RB (IL-17 Receptor “B”) activation through its ligand IL-25, while not being bound by this theory, presumably by affecting the heteromeric receptor complex comprising IL-17RA and IL-17RB. The IL-17RA-RB complex and the use of AM-14 in inhibiting the biological activity of IL-25 are described in PCT/US2009/001085 and is herein incorporated by reference in its entirety.
AM-14 comprises a heavy chain sequence comprising SEQ ID NO:1 (or alternatively the heavy chain sequence comprising SEQ ID NO:12 which has the COOH-terminus Lys removed from SEQ ID NO:1) and a light chain sequence comprising SEQ ID NO:2, or a human IL-17RA binding fragment thereof. AM-14 comprises a heavy chain variable region sequence comprising SEQ ID NO:3 and a light chain variable region sequence comprising SEQ ID NO:4, or a human IL-17RA binding fragment thereof, wherein said AM-14 antibody binds human IL-17RA. AM-14 comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:6 (or alternatively the heavy chain CDR2 comprising SEQ ID NO:7), a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, or a human IL-17RA binding fragment thereof, wherein said AM-14 antibody binds human IL-17RA.
As used herein, the term “biopharmaceutical” is intended to mean a macromolecule such as a polypeptide, nucleic acid, carbohydrate or lipid, or building block thereof, that is intended for use as a pharmaceutical, which in this instance is the antibody AM-14. A “biopharmaceutical formulation” refers to a pharmaceutically acceptable medium that is compatible with a biopharmaceutical and is safe and non-toxic when administered to humans.
The term “a” or “an”, refers to one or more, for example, “an immunoglobulin molecule,” is understood to represent one or more immunoglobulin molecules. As such, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein.
It is understood that when describing a range of values, the characteristic being described can be an individual value found within the range. For example, “a pH from about pH 4 to about pH 6,” can be, but is not limited to, pH 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, etc. and any value in between such values. Additionally, “a pH from about pH 4 to about pH 6,” should not be construed to mean that the pH of a formulation in question varies 2 pH units in the range from pH 4 to pH 6 during storage, but rather a value may be picked in that range for the pH of the solution, and the pH remains buffered at about that pH.
A formulation comprising a buffering solution and AM-14 is provided. The buffering solution may comprise a glutamic acid or an acetic acid buffer. The buffering solution comprises a glutamic acid buffer. The specification also provides a method of preparing the formulation, methods of treating a condition using the formulated AM-14, and a kit containing components of the formulation.
A highly significant advance has been made in the formulation of AM-14 (i.e., biopharmaceutical formulations of AM-14) in that high concentrations of AM-14 in solution have been achieved. Therefore, embodiments include highly concentrated AM-14 formulations. High concentration AM-14 formulations are desirable in that this allows lower volume administration and/or fewer administrations and consequently less discomfort to the patient.
An additional highly significant advance is that AM-14 formulations have comparatively low viscosity at high protein concentrations. AM-14 formulations having lower viscosity are highly desirable, in that this facilitates manufacturability (such as but not limited to processing, filtering, and filling), the use standard syringe and needle configurations (as appropriate for the route of administration), adaptability to art-known auto-injector and microinfusion devices, ease of administration, and reducing shear forces to AM-14 upon administration. An added benefit of lower viscosity AM-14 formulations is less discomfort to the patient upon administration.
A further highly significant advance over the art is that AM-14 formulations described herein having high concentration of AM-14 (i.e., >100 mg/ml) are surprisingly stable, as described in the stability studies in Example 1.
›DETAILED DESCRIPTION · 2 of 75
In addition, it has been surprisingly found that glutamate-based formulations at 10 mM glutamate do not induce unacceptable stinging/pain upon subcutaneous injection, as described in Example 5.
Embodiments of AM-14 formulations include a biopharmaceutical formulation of AM-14 having a concentration range of AM-14 in solution of 60 to 250 mg/ml, 60 to 240 mg/ml, 60 to 230 mg/ml, 60 to 220 mg/ml, 60 to 210 mg/ml, 60 to 200 mg/ml, 60 to 190 mg/ml, 60 to 180 mg/ml, 60 to 170 mg/ml, 60 to 160 mg/ml, 60 to 150 mg/ml, 60 to 140 mg/ml, 60 to 130 mg/ml, 60 to 120 mg/ml, 60 to 110 mg/ml, 60 to 100 mg/ml, 70 to 250 mg/ml, 70 to 240 mg/ml, 70 to 230 mg/ml, 70 to 220 mg/ml, 70 to 210 mg/ml, 70 to 200 mg/ml, 70 to 190 mg/ml, 70 to 180 mg/ml, 70 to 170 mg/ml, 70 to 160 mg/ml, 70 to 150 mg/ml, 70 to 140 mg/ml, 70 to 130 mg/ml, 70 to 120 mg/ml, 70 to 110 mg/ml, 70 to 100 mg/ml, 80 to 250 mg/ml, 80 to 240 mg/ml, 80 to 230 mg/ml, 80 to 220 mg/ml, 80 to 210 mg/ml, 80 to 200 mg/ml, 80 to 190 mg/ml, 80 to 180 mg/ml, 80 to 170 mg/ml, 80 to 160 mg/ml, 80 to 150 mg/ml, 80 to 140 mg/ml, 80 to 130 mg/ml, 80 to 120 mg/ml, 80 to 110 mg/ml, 80 to 100 mg/ml, 90 to 250 mg/ml, 90 to 240 mg/ml, 90 to 230 mg/ml, 90 to 220 mg/ml, 90 to 210 mg/ml, 90 to 200 mg/ml, 90 to 190 mg/ml, 90 to 180 mg/ml, 90 to 170 mg/ml, 90 to 160 mg/ml, 90 to 150 mg/ml, 90 to 140 mg/ml, 90 to 130 mg/ml, 90 to 120 mg/ml, 90 to 110 mg/ml, 90 to 100 mg/ml, 100 to 250 mg/ml, 100 to 240 mg/ml, 100 to 230 mg/ml, 100 to 220 mg/ml, 100 to 210 mg/ml, 100 to 200 mg/ml, 100 to 190 mg/ml, 100 to 180 mg/ml, 100 to 170 mg/ml, 100 to 160 mg/ml, 100 to 150 mg/ml, 100 to 140 mg/ml, 100 to 130 mg/ml, 100 to 120 mg/ml, 100 to 110 mg/ml, 110 to 250 mg/ml, 110 to 240 mg/ml, 110 to 230 mg/ml, 110 to 220 mg/ml, 110 to 210 mg/ml, 110 to 200 mg/ml, 110 to 190 mg/ml, 110 to 180 mg/ml, 110 to 170 mg/ml, 110 to 160 mg/ml, 110 to 150 mg/ml, 110 to 140 mg/ml, 110 to 130 mg/ml, 110 to 120 mg/ml, 120 to 250 mg/ml, 120 to 240 mg/ml, 120 to 230 mg/ml, 120 to 220 mg/ml, 120 to 210 mg/ml, 120 to 200 mg/ml, 120 to 190 mg/ml, 120 to 180 mg/ml, 120 to 170 mg/ml, 120 to 160 mg/ml, 120 to 150 mg/ml, 120 to 140 mg/ml, 120 to 130 mg/ml, 130 to 250 mg/ml, 130 to 240 mg/ml, 130 to 230 mg/ml, 130 to 220 mg/ml, 130 to 210 mg/ml, 130 to 200 mg/ml, 130 to 190 mg/ml, 130 to 180 mg/ml, 130 to 170 mg/ml, 130 to 160 mg/ml, 130 to 150 mg/ml, 130 to 140 mg/ml, 140 to 250 mg/ml, 140 to 240 mg/ml, 140 to 230 mg/ml, 140 to 220 mg/ml, 140 to 210 mg/ml, 140 to 200 mg/ml, 140 to 190 mg/ml, 140 to 180 mg/ml, 140 to 170 mg/ml, 140 to 160 mg/ml, 140 to 150 mg/ml, 150 to 250 mg/ml, 150 to 240 mg/ml, 150 to 230 mg/ml, 150 to 220 mg/ml, 150 to 210 mg/ml, 150 to 200 mg/ml, 150 to 190 mg/ml, 150 to 180 mg/ml, 150 to 170 mg/ml, 150 to 160 mg/ml, 160 to 250 mg/ml, 160 to 240 mg/ml, 160 to 230 mg/ml, 160 to 220 mg/ml, 160 to 210 mg/ml, 160 to 200 mg/ml, 160 to 190 mg/ml, 160 to 180 mg/ml, 160 to 170 mg/ml, 180 to 250 mg/ml, 180 to 240 mg/ml, 180 to 230 mg/ml, 180 to 220 mg/ml, 180 to 210 mg/ml, 180 to 200 mg/ml, 180 to 190 mg/ml, 190 to 250 mg/ml, 190 to 240 mg/ml, 190 to 230 mg/ml, 190 to 220 mg/ml, 190 to 210 mg/ml, 190 to 200 mg/ml, 200 to 250 mg/ml, 200 to 240 mg/ml, 200 to 230 mg/ml, 200 to 220 mg/ml, 200 to 210 mg/ml, 210 to 250 mg/ml, 210 to 240 mg/ml, 210 to 230 mg/ml, 210 to 220 mg/ml, 220 to 250 mg/ml, 220 to 240 mg/ml, 220 to 230 mg/ml, 230 to 250 mg/ml, 230 to 240 mg/ml, or 240 to 250 mg/ml.
Embodiments of AM-14 formulations include a biopharmaceutical formulation of AM-14 having a concentration of at least 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, or 250 mg/ml. Embodiments of AM-14 formulations include a biopharmaceutical formulation of AM-14 having a concentration of 100-150 mg/ml±0.01-5%. Embodiments of AM-14 formulations include a biopharmaceutical formulation of AM-14 having a concentration of 140 mg/ml±0.01-5%.
Embodiments of AM-14 formulations comprise an acetic acid or glutamic acid buffer wherein the acetic acid or glutamic acid buffer concentration is from about 5 to 30±0.2 mM, including 5±0.2, 6±0.2, 7±0.2, 8±0.2, 9±0.2, 10±0.2, 11±0.2, 12±0.2, 13±0.2, 14±0.2, 15±0.2, 16±0.2, 17±0.2, 18±0.2, 19±0.2, 20±0.2, 21±0.2, 22±0.2, 23±0.2, 24±0.2, 25±0.2, 26±0.2, 27±0.2, 28±0.2, 29±0.2, or 30±0.2 mM. Embodiments of AM-14 formulations comprise a glutamic acid buffer wherein the glutamic acid buffer concentration is 10±0.2 mM.
As used herein, the term “acetic acid buffer” is intended to mean a buffer comprising acetic acid. The buffer can be made from an acetate salt, for example, sodium acetate. Other salts can be used, for example, potassium, ammonium, calcium or magnesium salts of acetate. “Acetic acid buffer” and “acetate buffer” are used interchangeably.
As used herein, the term “glutamic acid buffer” is intended to mean a buffer comprising glutamic acid. The buffer can be made from a glutamate salt, for example, sodium glutamate. Other salts can be used, for example, potassium, ammonium, calcium or magnesium salts of glutamate. “Glutamic acid buffer” and “glutamate buffer” are used interchangeably. In other embodiments, the glutamic acid and/or the acetic acid buffers can be used in combination with proline as an excipient (including L-proline).
›DETAILED DESCRIPTION · 3 of 75
Embodiments of AM-14 formulations comprise an acetic acid or glutamic acid buffer having a pH of 4.5 to 5.5±0.2, or a range of 4.8 to 5.2±0.2, including a pH of 4.6±0.2, 4.7±0.2, 4.8±0.2, 4.9±0.2, 5.0±0.2, 5.1±0.2, 5.2±0.2, 5.3±0.2, 5.4±0.2, and 5.5±0.2. Embodiments of AM-14 formulations comprise a glutamic acid buffer having a pH of 4.8±0.2.
As used herein, the term “excipient” is intended to mean a therapeutically inactive substance. Excipients can be included in a biopharmaceutical formulation for a wide variety of purposes including, for example, as a diluent, vehicle, buffer, stabilizer, tonicity agent, bulking agent, surfactant, cryoprotectant, lyoprotectant, anti-oxidant, metal ion source, chelating agent and/or preservative. Optimal excipients also are chosen to enhance or provide stabilization with reference to the mode of administration for an aqueous biopharmaceutical formulation of the invention. For example, parenteral routes of intravenous (IV), subcutaneous (SC) or intramuscular (IM) administration can be more safe and efficacious when all components of the formulation maintain physical and chemical stability during manufacture, storage and administration. The excipients exemplified herein for use in a biopharmaceutical formulation exhibit these and other characteristics. Excipients are well known in the art and can be found described in, for example, Wang W., Int. J. Pharm. 185:129-88 (1999) and Wang W., Int. J. Pharm. 203:1-60 (2000).
Excipients include, for example, polyols such as sorbitol or mannitol; sugars such as sucrose, lactose or dextrose; polymers such as polyethylene glycol; salts such as NaCl, KCl or calcium phosphate, amino acids such as glycine, methionine or glutamic acid, surfactants, metal ions, buffer salts such as propionate, acetate or succinate, preservatives and polypeptides such as human serum albumin, as well as saline and water. Other excipients useful in either a liquid or lyophilized biopharmaceutical formulation of the invention include, for example, fucose, cellobiose, maltotriose, melibiose, octulose, ribose, xylitol, arginine, histidine, glycine, alanine, methionine, glutamic acid, lysine, imidazole, glycylglycine, mannosylglycerate, Triton X-100, Pluoronic F-127, cellulose, cyclodextrin, dextran (10, 40 and/or 70 kD), polydextrose, maltodextrin, ficoll, gelatin, hydroxypropylmeth, sodium phosphate, potassium phosphate, ZnCl2, zinc, zinc oxide, sodium citrate, trisodium citrate, tromethamine, copper, fibronectin, heparin, human serum albumin, protamine, glycerin, glycerol, EDTA, metacresol, benzyl alcohol and phenol. Sugar alcohols, also known as a polyols, polyhydric alcohols, or polyalcohols, are hydrogenated forms of carbohydrate having a carbonyl group reduced to a primary or secondary hydroxyl group. Polyols can be used as stabilizing excipients and/or isotonicity agents in both liquid and lyophilized formulations. Polyols can protect biopharmaceuticals from both physical and chemical degradation pathways. Preferentially excluded co-solvents increase the effective surface tension of solvent at the protein interface whereby the most energetically favorable structural conformations are those with the smallest surface areas. Specific examples of sugar alcohols include sorbitol, glycerol, mannitol, xylitol, maltitol, lactitol, erythritol and threitol. Reducing sugars include, for example, sugars with a ketone or aldehyde group and contain a reactive hemiacetal group, which allows the sugar to act as a reducing agent. Specific examples of reducing sugars include fructose, glucose, glyceraldehyde, lactose, arabinose, mannose, xylose, ribose, rhamnose, galactose and maltose. Non-reducing sugars contain an anomeric carbon that is an acetal and is not substantially reactive with amino acids or polypeptides to initiate a Maillard reaction. Specific examples of non-reducing sugars include sucrose, trehalose, sorbose, sucralose, melezitose and raffinose. Sugar acids include, for example, saccharic acids, gluconate and other polyhydroxy sugars and salts thereof.
Embodiments of AM-14 formulations include sucrose, glycine, proline, glycerol, and/or sorbitol as excipients, which can be included at concentration ranges of about 1 to 20% (w/v)±0.2% (w/v), or a range of 5 to 10% (w/v)±0.2% (w/v), or a range of 3 to 9% (w/v)±0.2% (w/v), including a concentration of 1±0.2, 2±0.2, 3±0.2, 4±0.2, 5±0.2, 6±0.2, 7±0.2, 8±0.2, 9±0.2, 10±0.2, 11±0.2, 12±0.2, 13±0.2, 14±0.2, 15±0.2, 16±0.2, 17±0.2, 18±0.2, 19±0.2, or 20%±0.2% (w/v).
As used herein, the term “surfactant” is intended to mean a substance that functions to reduce the surface tension of a liquid in which it is dissolved. Surfactants can be included in a biopharmaceutical formulation for a variety of purposes including, for example, to prevent or control aggregation, particle formation and/or surface adsorption in liquid formulations or to prevent or control these phenomena during the lyophilization and/or reconstitution process in lyophilized formulations. Surfactants include, for example, amphipathic organic compounds that exhibit partial solubility in both organic solvents and aqueous solutions. General characteristics of surfactants include their ability to reduce the surface tension of water, reduce the interfacial tension between oil and water and also form micelles. Surfactants of the invention include non-ionic and ionic surfactants. Surfactants are well known in the art and can be found described in, for example, Randolph T. W. and Jones L. S., Surfactant-protein interactions. Pharm Biotechnol. 13:159-75 (2002). Non-ionic surfactants include, for example, alkyl poly (ethylene oxide), alkyl polyglucosides such as octyl glucoside and decyl maltoside, fatty alcohols such as cetyl alcohol and oleyl alcohol, cocamide MEA, cocamide DEA, and cocamide TEA. Specific examples of non-ionic surfactants include the polysorbates including, for example, polysorbate 20, polysorbate 28, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 and the like; the poloxamers including, for example, poloxamer 188, also known as poloxalkol or poly(ethylene oxide)-poly(propylene oxide), poloxamer 407 or polyethylene-polypropylene glycol and the like, and polyethylene glycol (PEG). Polysorbate 20 is synonymous with TWEEN 20®, sorbitan monolaurate and polyoxyethylene sorbitan monolaurate. Ionic surfactants include, for example, anionic, cationic and zwitterionic surfactants. Anionic surfactants include, for example, sulfonate-based or carboxylate-based surfactants such as soaps, fatty acid salts, sodium dodecyl sulfate (SDS), ammonium lauryl sulfate and other alkyl sulfate salts. Cationic surfactants include, for example, quaternary ammonium-based surfactants such as cetyl trimethylammonium bromide (CTAB), other alkyltrimethylammonium salts, cetyl pyridinium chloride, polyethoxylated tallow amine (POEA) and benzalkonium chloride. Zwitterionic or amphoteric surfactants include, for example, dodecyl betaine, dodecyl dimethylamine oxide, cocamidopropyl betaine and coco ampho glycinate.
›DETAILED DESCRIPTION · 4 of 75
Embodiments of AM-14 formulations include polysorbate 20 (polyoxyethylene sorbitan monolaurate) as a surfactant, which can be included at concentration ranges of about 0.003 to 1% (w/v), or a range of about 0.008 to 0.02% (w/v) including 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1% (w/v). Embodiments of AM-14 formulations comprise glutamate based buffers comprising polysorbate 20 (polyoxyethylene sorbitan monolaurate) as a surfactant at concentration of about 0.005-0.02% (w/v). Embodiments of AM-14 formulations comprise polysorbate 20 (polyoxyethylene sorbitan monolaurate) as a surfactant at concentration of about 0.01% (w/v).
An AM-14 formulation can be prepared to be isotonic relative to a reference solution or fluid (i.e., blood serum). An isotonic solution has a substantially similar amount of dissolved solute in it compared to the things around it so that it is osmotically stable. Unless expressly compared to a specific solution or fluid, isotonic or isotonicity is exemplary used herein by reference to human blood serum (e.g., 300 mOsmol/kg). Therefore, an isotonic AM-14 formulation will contain a substantially similar concentration of solutes or exhibit substantially similar osmotic pressure as human blood. In general, an isotonic solution contains about the same concentration of solutes as normal saline for humans and many other mammals, which is about 0.9 weight percent (0.009 g/ml) salt in aqueous solution (e.g., 0.009 g/ml NaCl). Embodiments of AM-14 formulations include those that are isotonic or near isotonic and have an osmolarity range of about 250 to 400 osm/L or 275 to 325 osm/L, including an osmolarity of 250, 251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291, 292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 305, 306, 307, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328, 329, 330, 331, 332, 334, 335, 336, 337, 338, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 350, 351, 352, 353, 354, 355, 356, 357, 358, 359, 360, 361, 362, 363, 364, 365, 366, 367, 368, 369, 370, 371, 372, 373, 374, 375, 376, 377, 378, 379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 389, 390, 391, 392, 393, 394, 395, 396, 397, 398, 399, or 400 osm/L.
Embodiments of AM-14 formulations include those described herein that have low viscosity despite having a high concentration of antibody in solution. Embodiments of AM-14 formulations, such as those listed in the next paragraph, include AM-14 formulations having a viscosity of between 4 and 10 cP at 25 degrees C. Embodiments of AM-14 formulations, such as those listed in the next paragraph, include AM-14 formulations having a viscosity of between 5 and 7 cP at 25 degrees C. Embodiments of AM-14 formulations, such as those listed in the next paragraph, include AM-14 formulations having a viscosity of 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, or 10 cP at 25 degrees C. Of course it is understood that these ranges and values are not limited to the enumerated numbers and includes further fractional increments (for example 4.11, 4.12, 4.13, etc.).
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 7-9% (w/v) sucrose, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 1-3% (w/v) glycine, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 2-4% (w/v) proline, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
›DETAILED DESCRIPTION · 5 of 75
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 1-3% (w/v) glycine, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 2-4% (w/v) proline, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 7-9% (w/v) sucrose, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 2-4% (w/v) glycerol, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 3.5-5.5% (w/v) sorbitol, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 7-9% (w/v) sucrose, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.
›DETAILED DESCRIPTION · 6 of 75
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 1-3% (w/v) glycine, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 2-4% (w/v) proline, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 1-3% (w/v) glycine, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 2-4% (w/v) proline, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 7-9% (w/v) sucrose, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.
›DETAILED DESCRIPTION · 7 of 75
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 2-4% (w/v) glycerol, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.
Embodiments of AM-14 formulations include, but are not limited to 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 3.5-5.5% (w/v) sorbitol, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C. Embodiments of AM-14 formulations include about 105 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 110 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 120 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 130 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 140 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. Embodiments of AM-14 formulations include about 150 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. The term “about” means±0.01 to 5.0%.
Stability of an AM-14 biopharmaceutical formulation of the invention refers to the retention of structure and/or function of a biopharmaceutical within a formulation. A biopharmaceutical in a formulation of the invention will exhibit attributes such as resistance to change or deterioration that affect stability or function and therefore maintain consistent functional characteristics over time. Accordingly, AM-14 formulations will exhibit, for example, reliability and safety with respect to activity per volume or activity units.
In one embodiment, the stability of an AM-14 biopharmaceutical within a formulation of the invention includes, for example, the retention of physical and/or chemical stability. Biopharmaceutical stability of AM-14 can be assessed by, for example, determining whether the AM-14 has been subjected to physical and/or chemical degradation, including chemical modification of its structure. Stability may be measured by any means known in the art, such as measuring protein aggregates and/or protein break-down products by photometric and/or chromatographic methods. Retention in stability of a AM-14 in a formulation includes, for example, retention of physical and/or chemical stability between about 80-100%, including retention of stability at least about 99%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 91%, 90%, 89%, 88%, 87%, 86%, 85%, 84%, 83%, 82%, 81% or 80% compared to the stability of AM-14 at an initial time point. Example 1 describes such stability studies and exemplary means for measuring physical and/or chemical stability.
Embodiments include AM-14 formulations such as: 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 7-9% (w/v) sucrose, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2; such as 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2; 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 1-3% (w/v) glycine, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, such as 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2; 100-1500 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 2-4% (w/v) proline, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, such as about 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, and 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 1-3% (w/v) glycine, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 2-4% (w/v) proline, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 7-9% (w/v) sucrose, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 2-4% (w/v) glycerol, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 3.5-5.5% (w/v) sorbitol, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2; 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 7-9% (w/v) sucrose, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C., such as 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.; 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 1-3% (w/v) glycine, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C., such as 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.; 100-150 mg/mL AM-14, formulated with 5-15 mM glutamic acid, 2-4% (w/v) proline, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C., such as 140 mg/mL AM-14, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 1-3% (w/v) glycine, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C., such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 2% (w/v) glycine, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 2-4% (w/v) proline, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C., such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 7-9% (w/v) sucrose, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C., such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 8% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 2-4% (w/v) glycerol, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C., such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 3% (w/v) glycerol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C.; 100-150 mg/mL AM-14, formulated with 5-15 mM acetic acid, 3.5-5.5% (w/v) sorbitol, 0.003-0.02% (w/v) polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25 degrees C., such as 140 mg/mL AM-14, formulated with 10 mM acetic acid, 4.5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, 5-7 cP at 25 degrees C. having retention of physical and/or chemical stability between about 80-100%, including retention of stability at least about 99%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 91%, 90%, 89%, 88%, 87%, 86%, 85%, 84%, 83%, 82%, 81% or 80% compared to the stability of AM-14 at an initial time point.
›DETAILED DESCRIPTION · 8 of 75
A biopharmaceutical formulation of the invention will, in general, be prepared according to pharmaceutical standards and using pharmaceutical grade reagents. Similarly, a biopharmaceutical formulation of the invention will, in general, be prepared using sterile reagents in a sterile manufacturing environment or sterilized following preparation. Sterile injectable solutions can be prepared using well known procedures in the art including, for example, by incorporating AM-14 in a formulation described herein followed by sterilization microfiltration. In the specific embodiment of sterile powders for the preparation of sterile injectable solutions, particularly useful methods of preparation include, for example, vacuum drying and freeze-drying (lyophilization) as described previously. Such drying methods will yield a powder of the one or more biopharmaceuticals together with any additional desired components from a previously sterile-filtered solution thereof.
Embodiments include pharmaceutical containers comprising a vessel and/or vessel means and a pharmaceutical formulation of AM-14 as disclosed herein. A vessel and/or vessel means is something that holds the pharmaceutical formulation of AM-14 and can be any suitable vessel known in the art, including, but not limited to a vial, bottle, syringe, or any of a variety of formats well known in the art for packaging pharmaceutical formulations, including subcutaneous and transdermal delivery devices. The syringe may be filled with a pharmaceutical formulation of AM-14 as disclosed herein prior to distribution to end users (i.e. “prefilled syringe”).
Embodiments of the invention include a prefilled syringe containing a pharmaceutical formulation of AM-14 as disclosed herein, wherein the prefilled syringe is in the form of an “autoinjector,” such as but not limited to SureClick®, EverGentle®, Avanti®, DosePro®, and Leva®, or a version thereof. Embodiments of the invention include a prefilled syringe containing AM-14 at about 140 mg/mL formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 in the form of an “autoinjector,” such as but not limited to SureClick®, EverGentle®, Avanti®, DosePro®, and Leva®, or a version thereof. Embodiments of the invention include a prefilled syringe containing a pharmaceutical formulation of AM-14 as disclosed herein, wherein the prefilled syringe is in the form of any suitable micro-infusion pump known in the art. Embodiments of the invention include a prefilled syringe in the form of a micro-infusion pump containing AM-14 at about 140 mg/mL, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. A “microinfuser” is any micro-infusion pump for subcutaneous drug delivery. Embodiments of the invention include transdermal delivery of a pharmaceutical formulation of AM-14 as disclosed herein. Embodiments of the invention include any transdermal delivery system containing AM-14 at about 140 mg/mL, formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2.
Kits are also embodiments of the invention and comprise one or more pharmaceutical containers of AM-14 described in the preceding paragraphs together with instructions on the use of AM-14. It is understood the kit may contain other components.
II. Formulations, Dosage and Treatment Regimens
AM-14 in a pharmaceutical composition comprising AM-14 at about 100-150 mg/mL formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, and in particular AM-14 in a pharmaceutical composition comprising AM-14 at about 140 mg/mL formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 may be used to treat adult, juvenile, and/or pediatric patient populations having diseases including, but are not limited to, IL-17-related inflammation, IL-17-related autoimmune disease, IL-17-related cartilage inflammation and/or bone degradation, arthritis, rheumatoid arthritis, SEA Syndrome (Seronegativity, Enthesopathy, Arthropathy Syndrome), pauciarticular rheumatoid arthritis, polyarticular rheumatoid arthritis, systemic onset rheumatoid arthritis, ankylosing spondylitis, enteropathic arthritis, reactive arthritis, Reiter's Syndrome, dermatomyositis, psoriatic arthritis, scleroderma, systemic lupus erythematosus, vasculitis, myolitis, polymyolitis, dermatomyolitis, osteoarthritis, polyarteritis nodossa, Wegener's granulomatosis, arteritis, polymyalgia rheumatica, sarcoidosis, scleroderma, sclerosis, primary biliary sclerosis, sclerosing cholangitis, Sjogren's syndrome, psoriasis, plaque psoriasis, guttate psoriasis, inverse psoriasis, pustular psoriasis, erythrodermic psoriasis, dermatitis, atopic dermatitis, atherosclerosis, lupus, Still's disease, Systemic Lupus Erythematosus (SLE), myasthenia gravis, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, celiac disease, multiple sclerosis (MS), asthma, COPD, Guillain-Barre disease, Type I diabetes mellitus, Graves' disease, Addison's disease, Raynaud's phenomenon, autoimmune hepatitis, GVHD, pernicious anemia, vitiligo, Kawasaki's Disease, ANCA-associated vasculitides, pemphigus bullous pemphigoid, autoimmune ovarian failure, Hashimoto's thyroiditis, uveitis, thrombotic thrombocytopenic, purpura, hemolytic uremic syndrome, periodic fever syndromes, familial mediterranean fever, TNF receptor-1 associated periodic syndrome, hyper-IgD syndrome, Marshall's syndrome, cryopyrin-associated periodic syndromes, PAPA (Pyogenic arthritis, pyoderma gangrenosum, and acne) syndrome, Blau syndrome, interstitial pneumonias (such as usual interstitial pneumonia, desquamative interstitial pneumonia, respiratory bronchiolitis associated interstitial lung disease, acute interstitial pneumonia, nonspecific interstitial pneumonia, lymphocytic interstitial pneumonia, cryptogenic organizing pneumonitis), pulmonary fibrosis, fibrosing syndromes (such as scleredema, scleromyxedema, overlap syndromes, nephrogenic systemic fibrosis, amyloidosis, eosinophilic fasciitis, chronic graft-versus-host disease, drug-induced scleroderma, and environmental exposure fibrosis), neutrophilic dermatoses (such as, pyoderma gangrenosum, SAPHO (synovitis, acne, pustulosis, hyperostosis, and osteitis) syndrome, palmoplantar pustulosis, subcorneal pustular dermatosis, bowel-associated dermatosis-arthritis syndrome, Behcet's disease, neutrophilic dermatoses associated with rheumatoid arthritis, rheumatoid neutrophilic dermatosis, neutrophilic eccrine hidradenitis, and neutrophilic dermatosis of the dorsal hands), sepsis/SIRS, post-cardiac injury syndrome, and Dressler's Syndrome, idiopathic arthritis, and the like.
›DETAILED DESCRIPTION · 9 of 75
AM-14 in a pharmaceutical composition comprising AM-14 at about 140 mg/mL formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 may be used to treat adult, juvenile, and/or pediatric patient populations having diseases including, but are not limited to, IL-17-related inflammation, IL-17-related autoimmune disease, IL-17-related cartilage inflammation and/or bone degradation, arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, scleroderma, psoriasis, plaque psoriasis, guttate psoriasis, dermatitis, atopic dermatitis, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, celiac disease, multiple sclerosis (MS), asthma, and COPD.
AM-14 in a pharmaceutical composition comprising AM-14 at about 140 mg/mL formulated with 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 may be used to treat adult, juvenile, and/or pediatric patient populations having diseases including, but are not limited to, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, plaque psoriasis, Crohn's disease, multiple sclerosis (MS), and asthma.
As described in Examples 2 and 6, AM-14 shows efficacy in treating psoriasis in human patients. Examples 2 and 6 provide clinical evidence of AM-14's efficacy in treating psoriasis in human patients having psoriasis, and in particular, plaque psoriasis. Subcutaneous and intravenous administration of AM-14 significantly reduced the symptoms of psoriasis. Example 2 describes the reduction in psoriatic symptoms, as measured by the art-accepted PASI scoring system. Tables 2.9, 2.9, 2.10, and 2.11 show PASI scores and % PASI (i.e., % reduction in PASI score).
Furthermore, sophisticated PK-PD modeling was performed based on the data from the Phase 1 psoriasis study (see Example 2). The predictive model correlated very closely to the actual PASI response data (see FIG. 11 ), which substantiates the validity of predicting efficacy for various doses. In addition, FIG. 12 shows the predicted time course of mean PASI response for four multiple dose scenarios (over 12 weeks) including placebo effect based on the model developed from single dose data. The modeled placebo response was assumed to act after only the first dose. The mean response for the 140 mg SC dose (at WK 0, 1, 2, 4, 6, 8, 10) was expected to exceed 50% PASI improvement for much of the study period including the 12 week (day 84) primary efficacy endpoint. The mean response for the 210 and 280 mg SC doses (at WK 0, 1, 2, 4, 6, 8, 10) was expected to exceed 75% PASI improvement for much of the study period including the 12 week (day 84) primary efficacy endpoint. And finally, FIG. 13 depicts the predicted week 12 median percent PASI improvement (dose-response curve) for AM-14, with 90% confidence interval shaded; for various dose levels each administered SC at week 0, 1, 2, 4, 6, 8, and 10.
Example 6 describes a Phase 2 study wherein AM-14 showed remarkable efficacy in treating psoriasis. Subjects received 70, 140, or 210 mg AM-14 at day 1 and weeks 1, 2, 4, 6, 8, and 10 or 280 mg at day 1 and weeks 4 and 8. AM-14 showed the following PASI responses at week 12: 70 mg dosing achieved a 33.3% PASI 75 response; 70 mg dosing achieved a 17.9% PASI 90 response; 70 mg dosing achieved a 10.3% PASI 100 response; 140 mg dosing achieved a 76.9% PASI 75 response; 140 mg dosing achieved a 71.8% PASI 90 response; 140 mg dosing achieved a 38.5% PASI 100 response; 210 mg dosing achieved a 82.5% PASI 75 response; 210 mg dosing achieved a 75.0% PASI 90 response; 210 mg dosing achieved a 62.5% PASI 100 response; 280 mg dosing achieved a 66.7% PASI 75 response; 280 mg dosing achieved a 57.1% PASI 90 response; and 280 mg dosing achieved a 28.6% PASI 100 response. Therefore, administration of AM-14 at the dosages and administration schedules described herein may be used to reduce the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%.
Based on all these findings, AM-14 can be used to treat the various forms of psoriasis disclosed above, and in particular plaque psoriasis, in adult and/or juvenile patients at a dose range of 70 to 1,000 mg per dose, and in particular a dose range of 70 to 700 mg per dose. AM-14 can be used to treat psoriasis, and in particular plaque psoriasis, in adult and/or juvenile patients having psoriasis at a dose range of about 140 to about 300 mg per dose. AM-14 can be used to treat psoriasis, and in particular plaque psoriasis, in adult and/or juvenile patients having psoriasis at a dose of 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235, 240, 245, 250, 255, 260, 265, 270, 275, 280, 285, 290, 295, 300, 305, 310, 315, 320, 325, 330, 335, 340, 345, 350, 355, 360, 365, 370, 375, 380, 385, 390, 395, 400, 405, 410, 415, 420, 425, 430, 435, 440, 445, 450, 455, 460, 465, 470, 475, 480, 485, 490, 495, 500, 505, 510, 515, 520, 525, 530, 535, 540, 545, 550, 555, 560, 565, 570, 575, 580, 585, 590, 595, 600, 605, 610, 615, 620, 625, 630, 635, 640, 645, 650, 655, 660, 665, 670, 675, 680, 685, 690, 695, 700, 705, 710, 715, 720, 725, 730, 735, 740, 745, 750, 755, 760, 765, 770, 775, 780, 785, 790, 795, 800, 805, 810, 815, 820, 825, 830, 835, 840, 845, 850, 855, 860, 865, 870, 875, 880, 885, 890, 895, 900, 905, 910, 915, 920, 925, 930, 935, 940, 945, 950, 955, 960, 965, 970, 975, 980, 985, 990, 995, and or 1,000 mg per dose.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose.
›DETAILED DESCRIPTION · 10 of 75
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection. AM-14 can be used to psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by syringe.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
›DETAILED DESCRIPTION · 11 of 75
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with at least one dose at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with at least one dose at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with at least one dose at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with at least one dose at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser.
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 12 of 75
AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
›DETAILED DESCRIPTION · 13 of 75
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by syringe.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 14 of 75
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose.
›DETAILED DESCRIPTION · 15 of 75
AM-14 can be used to adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by syringe.
›DETAILED DESCRIPTION · 16 of 75
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 17 of 75
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
›DETAILED DESCRIPTION · 18 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile psoriasis in patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
›DETAILED DESCRIPTION · 19 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by syringe.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe.
›DETAILED DESCRIPTION · 20 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 21 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 22 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by syringe.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
›DETAILED DESCRIPTION · 23 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with at least one dose at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with at least one dose at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with at least one dose at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy with at least one dose at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser.
›DETAILED DESCRIPTION · 24 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection.
›DETAILED DESCRIPTION · 25 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by syringe.
›DETAILED DESCRIPTION · 26 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with multiple dosing at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe.
›DETAILED DESCRIPTION · 27 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with at least one dose at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with at least one dose at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with at least one dose at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) with at least one dose at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser.
›DETAILED DESCRIPTION · 28 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 70 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 140 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 210 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy) at a dose of 280 mg per dose delivered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose every two weeks.
›DETAILED DESCRIPTION · 29 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose by subcutaneous injection to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
›DETAILED DESCRIPTION · 30 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
›DETAILED DESCRIPTION · 31 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-praline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
›DETAILED DESCRIPTION · 32 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 33 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
›DETAILED DESCRIPTION · 34 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-praline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-praline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
›DETAILED DESCRIPTION · 35 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 36 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, and in particular plaque psoriasis, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose every two weeks.
›DETAILED DESCRIPTION · 37 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose by subcutaneous injection to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
›DETAILED DESCRIPTION · 38 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
›DETAILED DESCRIPTION · 39 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
›DETAILED DESCRIPTION · 40 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
›DETAILED DESCRIPTION · 41 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 42 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 43 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 44 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
›DETAILED DESCRIPTION · 45 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose every two weeks.
›DETAILED DESCRIPTION · 46 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose by subcutaneous injection to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
›DETAILED DESCRIPTION · 47 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose by subcutaneous injection every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose by subcutaneous injection every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose by subcutaneous injection every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
›DETAILED DESCRIPTION · 48 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
›DETAILED DESCRIPTION · 49 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by autoinjector syringe every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser to patients weighing less than or approximately equal to 90 kg every two weeks and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose delivered by subcutaneous injection by microinfuser every two weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
›DETAILED DESCRIPTION · 50 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every four weeks to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose delivered by subcutaneous injection by microinfuser every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 51 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
›DETAILED DESCRIPTION · 52 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by autoinjector syringe administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 53 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by autoinjector syringe a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
›DETAILED DESCRIPTION · 54 of 75
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 100 kg and patients weighing greater than 100 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 140 mg dose to patients weighing less than or approximately equal to 110 kg and patients weighing greater than 110 kg are administered a 280 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered a 280 mg dose to patients weighing less than or approximately equal to 90 kg and patients weighing greater than 90 kg are administered a 210 mg dose, wherein the AM-14 is administered by subcutaneous injection by microinfuser administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 210 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 90 kg, and patients weighing greater than 90 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 100 kg, and patients weighing greater than 100 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks. AM-14 in a formulation comprising 140 mg/mL AM-14, 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and PUVA (psoralen plus ultraviolet-A phototherapy), wherein said patients are administered by subcutaneous injection by microinfuser a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every four weeks to patients weighing less than or approximately equal to 110 kg, and patients weighing greater than 110 kg are administered a 280 mg dose at time “0” (the first administration), at one week post time “0”, and every two weeks.
›DETAILED DESCRIPTION · 55 of 75
Administration and dosage regimens of AM-14 formulations can be adjusted to provide an effective amount for an optimum therapeutic response. For example, a single bolus can be administered, several divided doses can be administered over time or the dose can be proportionally reduced or increased as indicated by the exigencies of the therapeutic situation. AM-14 may be formulated for subcutaneous, intravenous, parenteral, intradermal, intramuscular, and/or intraperitoneal administration in a unit dosage form for ease of administration and uniformity of dosage. AM-14 formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 may be formulated for subcutaneous, intravenous, parenteral, intradermal, intramuscular, and/or intraperitoneal administration in a unit dosage form for ease of administration and uniformity of dosage. Unit dosing refers to a physically discrete amount of AM-14 suited as unitary dosages for the subjects to be treated; each unit contains a predetermined quantity of active biopharmaceutical calculated to produce a desired therapeutic effect.
AM-14 formulations may be administered subcutaneously, intravenously, parenterally, intradermally, intramuscularly, and/or intraperitoneally using standard techniques. AM-14 may be administered subcutaneously, intravenously, parenterally, intradermally, intramuscularly, and/or intraperitoneally at the dosages described above and in the formulations described herein for the treatment of the diseases listed above. AM-14 formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 may be administered subcutaneously, intravenously, parenterally, intradermally, intramuscularly, and/or intraperitoneally using standard techniques at the dosages and dosing regimens described above for the treatment of the psoriasis listed above. AM-14 formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 may be administered subcutaneously, intravenously, intradermally, and/or intramuscularly using standard techniques at the dosages and dosing regimens described above for the treatment of the psoriasis listed above. AM-14 may be formulated at about 140 mg/ml formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 may be administered subcutaneously, intravenously, intradermally, and/or intramuscularly using standard techniques at the dosages and dosing regimens described above for the treatment of the psoriasis listed above. AM-14 formulations, such as AM-14 formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, may be administered more than once at scheduled intervals over a period of time. In certain embodiments, AM-14 formulations, such as AM-14 formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, are administered over a period of at least a month or more. Embodiments include long-term treatment of the chronic conditions described above. Shorter periods of administration can be sufficient when treating acute conditions including, for example, from one to twenty four weeks. In general, AM-14 formulations are administered until the patient manifests a medically relevant degree of improvement over baseline for the chosen indicator or indicators as adjudged by a medical professional. Specifically, AM-14 formulations, such as AM-14 formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, may be administered once every week or 6 to 8 days, or every two weeks or 12 to 16 days, or every three weeks or 19 to 23 days, or every month or 26 to 30 days, or every five weeks or 33 to 34 days, or every six weeks or 40 to 44 days, or every seven weeks or 47 to 51 days, or every two months or 54 to 58 days subcutaneously, intravenously, parenterally, intradermally, intramuscularly, and/or intraperitoneally at the dosages described above and in the formulations described herein for an indefinite period of time for the treatment of the diseases and conditions described above, and in particular psoriasis.
Aspects of the invention include dosing regimens that further comprise a loading step. A “loading dose” refers to the step of initially administering at least one dose of an AM-14 formulation to the patient by any of the routes described above and prior to the administration of the same or lower dose at any of the intervals and routes described above. The initial dose or doses rapidly increase the serum drug concentration to an efficacious target serum concentration. The loading dose or series of loading doses is/are administered 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and/or 14 days prior to the normal course of dosing. It is understood that a “day” also includes any time interval between 1 and 24 hours. For example, as described above in more detail, AM-14 formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2, is administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration.
It is understood that the methods of treating the diseases described herein would administer an effective amount of an AM-14 formulation, such as AM-14 formulated in 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2. Depending on the indication to be treated, a therapeutically effective amount is sufficient to cause a reduction in at least one symptom of the targeted pathological condition by at least about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or more, relative to untreated subjects.
Aspects of the invention also include methods of regulating gene expression in psoriasis patients using AM-14. Example 3 describes in detail the genes that are regulated by AM-14. Thus, aspects of the invention include methods of regulating the genes in tables 3.1, 3.2, and/or 3.3 in psoriasis patients by administering AM-14. Aspects of the invention include the use of AM-14 for the preparation of a medicament for regulating the genes in tables 3.1, 3.2, and/or 3.3 in psoriasis patients. Further aspects described in Example 3 are also envisioned in methods of use, such as the temporal relationship between administration of AM-14 and gene regulation as well as the extent (e.g., fold change) of gene regulation and administration of AM-14.
›DETAILED DESCRIPTION · 56 of 75
Aspects of the invention also include methods of regulating gene expression in psoriasis patients using AM-14 and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%. Example 3 describes in detail the genes that are regulated by AM-14. Thus, aspects of the invention include methods of regulating the genes in tables 3.1, 3.2, and/or 3.3 and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients by administering AM-14. Aspects of the invention include the use of AM-14 for the preparation of a medicament for regulating the genes in tables 3.1, 3.2, and/or 3.3 and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients. Further aspects described in Example 3 are also envisioned in methods of use, such as the temporal relationship between administration of AM-14 and gene regulation as well as the extent (e.g., fold change) of gene regulation and administration of AM-14.
Aspects of the invention also include methods of regulating gene expression in 15 days or less in psoriasis patients using AM-14 and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%. Example 3 describes in detail the genes that are regulated by AM-14. Thus, aspects of the invention include methods of regulating the genes in tables 3.1, 3.2, and/or 3.3 in 15 days or less and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients by administering AM-14. Aspects of the invention include the use of AM-14 for the preparation of a medicament for regulating the genes in tables 3.1, 3.2, and/or 3.3 in 15 days or less and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients. Further aspects described in Example 3 are also envisioned in methods of use, such as the temporal relationship between administration of AM-14 and gene regulation as well as the extent (e.g., fold change) of gene regulation and administration of AM-14.
Aspects of the invention also include methods of regulating gene expression in psoriasis patients using IL-17 antagonistic antibodies. An “IL-17 antagonistic antibody” is an antibody that inhibits IL-17A or IL-17A/F from activating its cognate receptor(s) including IL-17RA, IL-17RC, and IL-17RA/RC. IL-17 antagonistic antibodies includes antibodies against IL-17RA or antibodies against IL-17A and/or IL-17A/F. Example 3 describes in detail the genes that are regulated by an exemplary antibody, AM-14. Thus, aspects of the invention include methods of regulating the genes in tables 3.1, 3.2, and/or 3.3 in psoriasis patients by administering an IL-17 antagonistic antibody. Aspects of the invention include the use of an IL-17 antagonistic antibody for the preparation of a medicament for regulating the genes in tables 3.1, 3.2, and/or 3.3 in psoriasis patients. Further aspects described in Example 3 are also envisioned in methods of use, such as the temporal relationship between administration of an IL-17 antagonistic antibody and gene regulation as well as the extent (e.g., fold change) of gene regulation and administration of an IL-17 antagonistic antibody.
Aspects of the invention also include methods of regulating gene expression and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients using IL-17 antagonistic antibodies. An “IL-17 antagonistic antibody” is an antibody that inhibits IL-17A or IL-17A/F from activating its cognate receptor(s) including IL-17RA, IL-17RC, and IL-17RA/RC. IL-17 antagonistic antibodies includes antibodies against IL-17RA or antibodies against IL-17A and/or IL-17A/F. Example 3 describes in detail the genes that are regulated by an exemplary antibody, AM-14. Thus, aspects of the invention include methods of regulating the genes in tables 3.1, 3.2, and/or 3.3 and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients by administering an IL-17 antagonistic antibody. Aspects of the invention include the use of an IL-17 antagonistic antibody for the preparation of a medicament for regulating the genes in tables 3.1, 3.2, and/or 3.3 and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients. Further aspects described in Example 3 are also envisioned in methods of use, such as the temporal relationship between administration of an IL-17 antagonistic antibody and gene regulation as well as the extent (e.g., fold change) of gene regulation and administration of an IL-17 antagonistic antibody.
Aspects of the invention also include methods of regulating gene expression in 15 days or less and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients using IL-17 antagonistic antibodies. An “IL-17 antagonistic antibody” is an antibody that inhibits IL-17A or IL-17A/F from activating its cognate receptor(s) including IL-17RA, IL-17RC, and IL-17RA/RC. IL-17 antagonistic antibodies includes antibodies against IL-17RA or antibodies against IL-17A and/or IL-17A/F. Example 3 describes in detail the genes that are regulated by an exemplary antibody, AM-14. Thus, aspects of the invention include methods of regulating the genes in tables 3.1, 3.2, and/or 3.3 in 15 days or less and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients by administering an IL-17 antagonistic antibody. Aspects of the invention include the use of an IL-17 antagonistic antibody for the preparation of a medicament for regulating the genes in tables 3.1, 3.2, and/or 3.3 in 15 days or less and concomitantly reducing the PASI score in a patient having psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% in psoriasis patients. Further aspects described in Example 3 are also envisioned in methods of use, such as the temporal relationship between administration of an IL-17 antagonistic antibody and gene regulation as well as the extent (e.g., fold change) of gene regulation and administration of an IL-17 antagonistic antibody.
›DETAILED DESCRIPTION · 57 of 75
Embodiments of the invention include those described above and throughout the specification, including:
1. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
2. The method of embodiment 1, wherein the psoriasis is plaque psoriasis.
3. The method of embodiment 2, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
4. The method of embodiment 3, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
5. The method of embodiment 3, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
6. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
7. The method of embodiment 6, wherein the psoriasis is plaque psoriasis.
8. The method of embodiment 6, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
9. The method of embodiment 8, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
10. The method of embodiment 8, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
11. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 140 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
12. The method of embodiment 11, wherein the psoriasis is plaque psoriasis.
13. The method of embodiment 12, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
14. The method of embodiment 13, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
15. The method of embodiment 13, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
16. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 210 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
17. The method of embodiment 16, wherein the psoriasis is plaque psoriasis.
18. The method of embodiment 17, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
19. The method of embodiment 18, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
20. The method of embodiment 18, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
21. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 280 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
›DETAILED DESCRIPTION · 58 of 75
22. The method of embodiment 21, wherein the psoriasis is plaque psoriasis.
23. The method of embodiment 22, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
24. The method of embodiment 23, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
25. The method of embodiment 23, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
26. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
27. The method of embodiment 26, wherein the psoriasis is plaque psoriasis.
28. The method of embodiment 27, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
29. The method of embodiment 28, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
30. The method of embodiment 28, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
31. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
32. The method of embodiment 31, wherein the psoriasis is plaque psoriasis.
33. The method of embodiment 32, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
34. The method of embodiment 33, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
35. The method of embodiment 33, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
36. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 140 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
37. The method of embodiment 36, wherein the psoriasis is plaque psoriasis.
38. The method of embodiment 36, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
39. The method of embodiment 38, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
40. The method of embodiment 38, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
41. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 210 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
42. The method of embodiment 41, wherein the psoriasis is plaque psoriasis.
43. The method of embodiment 42, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
44. The method of embodiment 43, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
45. The method of embodiment 43, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
46. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 280 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
›DETAILED DESCRIPTION · 59 of 75
47. The method of embodiment 46, wherein the psoriasis is plaque psoriasis.
48. The method of embodiment 47, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
49. The method of embodiment 48, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
50. The method of embodiment 48, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
51. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
52. The method of embodiment 51, wherein the psoriasis is plaque psoriasis.
53. The method of embodiment 52, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
54. The method of embodiment 53, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
55. The method of embodiment 53, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
56. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
57. The method of embodiment 56, wherein the psoriasis is plaque psoriasis.
58. The method of embodiment 57, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
59. The method of embodiment 58, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
60. The method of embodiment 58, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
61. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 140 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
62. The method of embodiment 61, wherein the psoriasis is plaque psoriasis.
63. The method of embodiment 62, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
64. The method of embodiment 63, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
65. The method of embodiment 63, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
66. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 210 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
67. The method of embodiment 66, wherein the psoriasis is plaque psoriasis.
68. The method of embodiment 67, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
69. The method of embodiment 68, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
70. The method of embodiment 68, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
71. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 280 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
72. The method of embodiment 71, wherein the psoriasis is plaque psoriasis.
73. The method of embodiment 72, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
74. The method of embodiment 73, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
›DETAILED DESCRIPTION · 60 of 75
75. The method of embodiment 73, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
76. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
77. The method of embodiment 76, wherein the psoriasis is plaque psoriasis.
78. The method of embodiment 77, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
79. The method of embodiment 78, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
80. The method of embodiment 78, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
81. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 70 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
82. The method of embodiment 81, wherein the psoriasis is plaque psoriasis.
83. The method of embodiment 82, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
84. The method of embodiment 83, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
85. The method of embodiment 83, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
86. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 140 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
87. The method of embodiment 86, wherein the psoriasis is plaque psoriasis.
88. The method of embodiment 87, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
89. The method of embodiment 88, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
90. The method of embodiment 88, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
91. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 210 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
92. The method of embodiment 91, wherein the psoriasis is plaque psoriasis.
93. The method of embodiment 92, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
94. The method of embodiment 93, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
95. The method of embodiment 93, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
›DETAILED DESCRIPTION · 61 of 75
96. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 280 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
97. The method of embodiment 96, wherein the psoriasis is plaque psoriasis.
98. The method of embodiment 97, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
99. The method of embodiment 98, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
100. The method of embodiment 99, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
101. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
102. The method of embodiment 101, wherein the psoriasis is plaque psoriasis.
103. The method of embodiment 102, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
104. The method of embodiment 103, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
105. The method of embodiment 103, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
106. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 70 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
107. The method of embodiment 106, wherein the psoriasis is plaque psoriasis.
108. The method of embodiment 107, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
109. The method of embodiment 108, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
110. The method of embodiment 108, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
111. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 140 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
112. The method of embodiment 111, wherein the psoriasis is plaque psoriasis.
113. The method of embodiment 112, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
114. The method of embodiment 113, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
115. The method of embodiment 113, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
116. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 210 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
›DETAILED DESCRIPTION · 62 of 75
117. The method of embodiment 116, wherein the psoriasis is plaque psoriasis.
118. The method of embodiment 117, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
119. The method of embodiment 118, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
120. The method of embodiment 118, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
121. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 280 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
122. The method of embodiment 121, wherein the psoriasis is plaque psoriasis.
123. The method of embodiment 122, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
124. The method of embodiment 123, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
125. The method of embodiment 123, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
126. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
127. The method of embodiment 126, wherein the psoriasis is plaque psoriasis.
128. The method of embodiment 127, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
129. The method of embodiment 128, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
130. The method of embodiment 128, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
131. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 70 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
132. The method of embodiment 131, wherein the psoriasis is plaque psoriasis.
133. The method of embodiment 132, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
134. The method of embodiment 133, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
135. The method of embodiment 133, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
136. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 140 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
137. The method of embodiment 136, wherein the psoriasis is plaque psoriasis.
138. The method of embodiment 137, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
139. The method of embodiment 138, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
140. The method of embodiment 138, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
141. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 210 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
›DETAILED DESCRIPTION · 63 of 75
142. The method of embodiment 141, wherein the psoriasis is plaque psoriasis.
143. The method of embodiment 142, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
144. The method of embodiment 143, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
145. The method of embodiment 143, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
146. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising 10 mM glutamic acid, 3% (w/v) L-proline, 0.01% (w/v) polysorbate 20, pH 4.8±0.2 and 140 mg/mL of an isolated antibody in a single or divided dose of about 280 mg antibody per dose, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
147. The method of embodiment 146, wherein the psoriasis is plaque psoriasis.
148. The method of embodiment 147, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
149. The method of embodiment 148, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
150. The method of embodiment 148, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
151. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
152. The method of embodiment 151, wherein the psoriasis is plaque psoriasis.
153. The method of embodiment 152, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
154. The method of embodiment 153, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
155. The method of embodiment 153, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
156. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 70 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
157. The method of embodiment 156, wherein the psoriasis is plaque psoriasis.
158. The method of embodiment 157, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
159. The method of embodiment 158, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
160. The method of embodiment 158, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
161. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
162. The method of embodiment 161, wherein the psoriasis is plaque psoriasis.
163. The method of embodiment 162, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
164. The method of embodiment 163, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
›DETAILED DESCRIPTION · 64 of 75
165. The method of embodiment 163, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
166. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 210 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
167. The method of embodiment 166, wherein the psoriasis is plaque psoriasis.
168. The method of embodiment 167, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
169. The method of embodiment 168, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
170. The method of embodiment 168, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
171. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
172. The method of embodiment 171, wherein the psoriasis is plaque psoriasis.
173. The method of embodiment 172, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
174. The method of embodiment 173, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
175. The method of embodiment 173, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
176. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
177. The method of embodiment 176, wherein the psoriasis is plaque psoriasis.
178. The method of embodiment 177, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
179. The method of embodiment 178, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
180. The method of embodiment 178, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
181. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 70 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
182. The method of embodiment 181, wherein the psoriasis is plaque psoriasis.
183. The method of embodiment 182, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
184. The method of embodiment 183, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
185. The method of embodiment 183, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
›DETAILED DESCRIPTION · 65 of 75
186. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
187. The method of embodiment 186, wherein the psoriasis is plaque psoriasis.
188. The method of embodiment 187, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
189. The method of embodiment 188, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
190. The method of embodiment 188, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
191. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 210 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
192. The method of embodiment 191, wherein the psoriasis is plaque psoriasis.
193. The method of embodiment 192, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
194. The method of embodiment 193, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
195. The method of embodiment 193, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
196. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
197. The method of embodiment 196, wherein the psoriasis is plaque psoriasis.
198. The method of embodiment 197, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
199. The method of embodiment 198, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
200. The method of embodiment 198, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
201. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
202. The method of embodiment 201, wherein the psoriasis is plaque psoriasis.
203. The method of embodiment 202, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
204. The method of embodiment 203, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
205. The method of embodiment 203, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
206. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 70 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
›DETAILED DESCRIPTION · 66 of 75
207. The method of embodiment 206, wherein the psoriasis is plaque psoriasis.
208. The method of embodiment 207, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
209. The method of embodiment 208, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
210. The method of embodiment 208, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
211. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
212. The method of embodiment 211, wherein the psoriasis is plaque psoriasis.
213. The method of embodiment 212, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
214. The method of embodiment 213, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
215. The method of embodiment 213, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
216. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 210 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
217. The method of embodiment 216, wherein the psoriasis is plaque psoriasis.
218. The method of embodiment 217, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
219. The method of embodiment 218, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
220. The method of embodiment 218, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
221. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered every two weeks following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
222. The method of embodiment 221, wherein the psoriasis is plaque psoriasis.
223. The method of embodiment 222, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
224. The method of embodiment 223, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
225. The method of embodiment 223, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
226. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
227. The method of embodiment 226, wherein the psoriasis is plaque psoriasis.
228. The method of embodiment 227, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
229. The method of embodiment 228, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
230. The method of embodiment 228, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
›DETAILED DESCRIPTION · 67 of 75
231. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 70 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
232. The method of embodiment 231, wherein the psoriasis is plaque psoriasis.
233. The method of embodiment 232, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
234. The method of embodiment 233, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
235. The method of embodiment 233, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
236. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
237. The method of embodiment 236, wherein the psoriasis is plaque psoriasis.
238. The method of embodiment 237, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
239. The method of embodiment 238, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
240. The method of embodiment 238, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
241. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 210 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
242. The method of embodiment 241, wherein the psoriasis is plaque psoriasis.
243. The method of embodiment 242, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
244. The method of embodiment 243, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
245. The method of embodiment 243, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
246. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
247. The method of embodiment 246, wherein the psoriasis is plaque psoriasis.
248. The method of embodiment 247, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
249. The method of embodiment 248, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
250. The method of embodiment 248, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
251. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
›DETAILED DESCRIPTION · 68 of 75
252. The method of embodiment 251, wherein the psoriasis is plaque psoriasis.
253. The method of embodiment 252, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
254. The method of embodiment 253, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
255. The method of embodiment 253, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
256. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 70 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
257. The method of embodiment 256, wherein the psoriasis is plaque psoriasis.
258. The method of embodiment 257, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
259. The method of embodiment 258, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
260. The method of embodiment 258, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
261. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
262. The method of embodiment 261, wherein the psoriasis is plaque psoriasis.
263. The method of embodiment 262, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
264. The method of embodiment 263, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
265. The method of embodiment 263, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
266. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 210 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
267. The method of embodiment 266, wherein the psoriasis is plaque psoriasis.
268. The method of embodiment 267, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
269. The method of embodiment 268, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
270. The method of embodiment 268, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
271. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
272. The method of embodiment 271, wherein the psoriasis is plaque psoriasis.
273. The method of embodiment 272, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
274. The method of embodiment 273, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
275. The method of embodiment 273, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
›DETAILED DESCRIPTION · 69 of 75
276. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of about 70 to about 300 mg antibody per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
277. The method of embodiment 276, wherein the psoriasis is plaque psoriasis.
278. The method of embodiment 277, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
279. The method of embodiment 278, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
280. The method of embodiment 278, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
281. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 70 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
282. The method of embodiment 281, wherein the psoriasis is plaque psoriasis.
283. The method of embodiment 282, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
284. The method of embodiment 283, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
285. The method of embodiment 283, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
286. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
287. The method of embodiment 286, wherein the psoriasis is plaque psoriasis.
288. The method of embodiment 287, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
289. The method of embodiment 288, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
290. The method of embodiment 288, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
291. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 210 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
292. The method of embodiment 291, wherein the psoriasis is plaque psoriasis.
293. The method of embodiment 292, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
294. The method of embodiment 293, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
295. The method of embodiment 293, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
296. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg per dose administered at time “0” (the first administration), at one week post time “0”, and then administered monthly following the week one administration, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain sequence comprising SEQ ID NO:1 and a light chain sequence comprising SEQ ID NO:2.
297. The method of embodiment 296, wherein the psoriasis is plaque psoriasis.
298. The method of embodiment 297, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
299. The method of embodiment 298, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
›DETAILED DESCRIPTION · 70 of 75
300. The method of embodiment 298, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
301. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 90 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 90 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
302. The method of embodiment 301, wherein the psoriasis is plaque psoriasis.
303. The method of embodiment 302, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
304. The method of embodiment 303, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
305. The method of embodiment 303, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
306. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 100 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 100 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
307. The method of embodiment 306, wherein the psoriasis is plaque psoriasis.
308. The method of embodiment 307, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
309. The method of embodiment 308, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
310. The method of embodiment 308, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
311. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 110 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 110 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
312. The method of embodiment 311, wherein the psoriasis is plaque psoriasis.
313. The method of embodiment 312, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
314. The method of embodiment 313, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
315. The method of embodiment 313, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
316. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 90 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 90 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
317. The method of embodiment 316, wherein the psoriasis is plaque psoriasis.
318. The method of embodiment 317, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
319. The method of embodiment 318, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
320. The method of embodiment 318, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
›DETAILED DESCRIPTION · 71 of 75
321. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 100 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 100 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
322. The method of embodiment 321, wherein the psoriasis is plaque psoriasis.
323. The method of embodiment 322, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
324. The method of embodiment 323, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
325. The method of embodiment 323, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
326. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 110 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 110 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
327. The method of embodiment 326, wherein the psoriasis is plaque psoriasis.
328. The method of embodiment 327, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
329. The method of embodiment 328, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
330. The method of embodiment 328, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
331. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 90 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 90 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
332. The method of embodiment 331, wherein the psoriasis is plaque psoriasis.
333. The method of embodiment 332, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
334. The method of embodiment 333, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
335. The method of embodiment 333, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
336. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 100 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 100 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
337. The method of embodiment 336, wherein the psoriasis is plaque psoriasis.
338. The method of embodiment 337, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
339. The method of embodiment 338, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
340. The method of embodiment 338, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
341. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 110 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 110 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
›DETAILED DESCRIPTION · 72 of 75
342. The method of embodiment 341, wherein the psoriasis is plaque psoriasis.
343. The method of embodiment 342, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
344. The method of embodiment 343, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
345. The method of embodiment 343, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
346. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 90 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 90 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
347. The method of embodiment 346, wherein the psoriasis is plaque psoriasis.
348. The method of embodiment 347, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
349. The method of embodiment 348, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
350. The method of embodiment 348, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
351. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 100 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 100 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
352. The method of embodiment 351, wherein the psoriasis is plaque psoriasis.
353. The method of embodiment 352, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
354. The method of embodiment 353, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
355. The method of embodiment 323, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
356. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 110 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 110 kg, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO:5, a heavy chain CDR2 comprising SEQ ID NO:7, a heavy chain CDR3 comprising SEQ ID NO:8, a light chain CDR1 comprising SEQ ID NO:9, a light chain CDR2 comprising SEQ ID NO:10, and a light chain CDR3 comprising SEQ ID NO:11, and wherein said antibody specifically binds human IL-17 receptor A.
357. The method of embodiment 356, wherein the psoriasis is plaque psoriasis.
358. The method of embodiment 357, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
359. The method of embodiment 358, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
360. The method of embodiment 358, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
361. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 90 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 90 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
362. The method of embodiment 361, wherein the psoriasis is plaque psoriasis.
363. The method of embodiment 362, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
›DETAILED DESCRIPTION · 73 of 75
364. The method of embodiment 363, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
365. The method of embodiment 363, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
366. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 100 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 100 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
367. The method of embodiment 366, wherein the psoriasis is plaque psoriasis.
368. The method of embodiment 367, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
369. The method of embodiment 368, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
370. The method of embodiment 368, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
371. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 110 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 110 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
372. The method of embodiment 371, wherein the psoriasis is plaque psoriasis.
373. The method of embodiment 372, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
374. The method of embodiment 373, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
375. The method of embodiment 373, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
376. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 90 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 90 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
377. The method of embodiment 376, wherein the psoriasis is plaque psoriasis.
378. The method of embodiment 377, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
379. The method of embodiment 378, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
380. The method of embodiment 378, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
381. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 100 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 100 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
382. The method of embodiment 381, wherein the psoriasis is plaque psoriasis.
383. The method of embodiment 382, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
384. The method of embodiment 383, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
385. The method of embodiment 383, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
›DETAILED DESCRIPTION · 74 of 75
386. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 110 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 110 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
387. The method of embodiment 386, wherein the psoriasis is plaque psoriasis.
388. The method of embodiment 387, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
389. The method of embodiment 388, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
390. The method of embodiment 388, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
391. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 90 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 90 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
392. The method of embodiment 391, wherein the psoriasis is plaque psoriasis.
393. The method of embodiment 392, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
394. The method of embodiment 393, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
395. The method of embodiment 393, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
396. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 100 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 100 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
397. The method of embodiment 396, wherein the psoriasis is plaque psoriasis.
398. The method of embodiment 397, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
399. The method of embodiment 398, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
400. The method of embodiment 398, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
401. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 110 kg and a single or divided dose of 210 mg every two weeks to patients weighing greater than 110 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
402. The method of embodiment 401, wherein the psoriasis is plaque psoriasis.
403. The method of embodiment 402, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
404. The method of embodiment 403, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
405. The method of embodiment 403, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
406. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 90 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 90 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
›DETAILED DESCRIPTION · 75 of 75
407. The method of embodiment 406, wherein the psoriasis is plaque psoriasis.
408. The method of embodiment 407, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
409. The method of embodiment 408, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
410. The method of embodiment 408, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
411. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 100 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 100 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
412. The method of embodiment 411, wherein the psoriasis is plaque psoriasis.
413. The method of embodiment 412, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
414. The method of embodiment 413, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
415. The method of embodiment 413, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
416. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 280 mg every four weeks to patients weighing less than or approximately equal to 110 kg and a single or divided dose of 280 mg every two weeks to patients weighing greater than 110 kg, wherein said antibody, or IL-17RA-binding fragment thereof, comprises a heavy chain variable domain sequence comprising SEQ ID NO:3 and a light chain variable domain sequence comprising SEQ ID NO:4, and wherein said antibody specifically binds human IL-17 receptor A.
417. The method of embodiment 416, wherein the psoriasis is plaque psoriasis.
418. The method of embodiment 417, wherein the plaque psoriasis is moderate to severe plaque psoriasis.
419. The method of embodiment 418, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.
420. The method of embodiment 418, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate, and psoralen plus ultraviolet-A phototherapy.
421. A method of treating psoriasis in adult and/or juvenile patients having psoriasis, comprising administering to said patient a pharmaceutical composition comprising an isolated antibody in a single or divided dose of 140 mg every two weeks to patients weighing less than or approximately equal to 90 kg and a single or d
›Tables in the description — 18
| AM-14 full- | SEQ ID NO: 1 | QVQLVQSGAEVKKPGASVKVSCKASGYTFTR |
| length | YGISWVRQAPGQGLEWMGWISTYSGNTNYA | |
| heavy | QKLQGRVTMTTDTSTSTAYMELRSLRSDDTA | |
| chain | VYYCARRQLYFDYWGQGTLVTVSSASTKGPS | |
| VFPLAPCSRSTSESTAALGCLVKDYFPEPVTV | ||
| SWNSGALTSGVHTFPAVLQSSGLYSLSSVVT | ||
| VPSSNFGTQTYTCNVDHKPSNTKVDKTVERK | ||
| CCVECPPCPAPPVAGPSVFLFPPKPKDTLMIS | ||
| RTPEVTCVVVDVSHEDPEVQFNWYVDGVEV | ||
| HNAKTKPREEQFNSTFRVVSVLTVVHQDWLN | ||
| GKEYKCKVSNKGLPAPIEKTISKTKGQPREPQ | ||
| VYTLPPSREEMTKNQVSLTCLVKGFYPSDIAV | ||
| EWESNGQPENNYKTTPPMLDSDGSFFLYSKL | ||
| TVDKSRWQQGNVFSCSVMHEALHNHYTQKS | ||
| LSLSPGK |
| Reconstitution | Viscosity | AM-14 Final | ||
| Buffer/pH | Excipient | (cP) | pH | Clarity |
| 10 mM glutamate, | 4% sorbitol | 19.64 | 5.24 | clear |
| pH 4.5 | ||||
| 10 mM glutamate, | 200 mM | 32.31 | 5.29 | clear |
| pH 4.5 | PEG200 | |||
| 10 mM glutamate, | 2.5% | 18.29 | 5.24 | clear |
| pH 4.5 | glycerol | |||
| (271.5 mM) | ||||
| 10 mM glutamate, | 3% proline | 19.99 | 5.28 | clear |
| pH 4.5 | (260 mM) | |||
| 10 mM glutamate, | 160 mM | 12.50 | 4.98 | clear |
| pH 4.5 | glutamic | |||
| acid | ||||
| 10 mM glutamate, | 200 mM | 11.89 | 4.6 | clear |
| pH 4.5 | creatinine | |||
| 10 mM glutamate, | 200 mM L- | 12.85 | 4.8 | clear |
| pH 4.5 | carnitine | |||
| 10 mM glutamate, | 50 mM | 17.15 | 5.2 | clear |
| pH 4.5 | creatinine + | |||
| 70 mM | ||||
| NaCl | ||||
| 10 mM glutamate, | 50 mM | 12.77 | 4.9 | clear |
| pH 4.5 | creatinine + | |||
| 110 mM | ||||
| glutamic | ||||
| acid | ||||
| 10 mM glutamate, | 80 mM | 14.85 | 5.05 | clear |
| pH 4.5 | arginine + | |||
| 80 mM | ||||
| glutamic | ||||
| acid | ||||
| 10 mM glutamate, | 130 mM | 17.25 | 5.39 | clear |
| pH 4.5 | proline + | |||
| 70 mM | ||||
| NaCl | ||||
| 10 mM glutamate, | 160 mM | 15.42 | 5.12 | clear |
| pH 4.5 | glycine | |||
| 10 mM glutamate, | 160 mM | 20.75 | 5.13 | clear |
| pH 4.5 | betaine | |||
| 10 mM glutamate, | 4% sorbitol | 44.20 | 5.6 | clear |
| pH 5.5 | ||||
| 10 mM glutamate, | 200 mM | 39.45 | 5.6 | clear |
| pH 5.5 | PEG200 | |||
| 10 mM glutamate, | 2.5% | 34.5 | 5.6 | clear |
| pH 5.5 | glycerol | |||
| (271.5 mM) | ||||
| 10 mM glutamate, | 3% proline | 27.3 | 5.65 | clear |
| pH 5.5 | (260 mM) | |||
| 10 mM glutamate, | 160 mM | 19.02 | 5.7 | clear |
| pH 5.5 | glutamic | |||
| acid | ||||
| 10 mM glutamate, | 160 mM | 15.74 | 5.7 | clear |
| pH 5.5 | arginine- | |||
| HCl, pH 5.5 | ||||
| 10 mM glutamate, | 200 mM | 15.22 | 5.6 | clear |
| pH 5.5 | creatinine | |||
| 10 mM glutamate, | 200 mM L- | 18.07 | 5.6 | clear |
| pH 5.5 | carnitine | |||
| 10 mM glutamate, | 50 mM | 24.62 | 6.08 | clear |
| pH 5.5 | creatinine + | |||
| 70 mM | ||||
| NaCl | ||||
| 10 mM glutamate, | 50 mM | 17.97 | 5.7 | clear |
| pH 5.5 | creatinine + | |||
| 110 mM | ||||
| glutamic | ||||
| acid | ||||
| 10 mM glutamate, | 80 mM | 17.42 | 5.69 | clear |
| pH 5.5 | arginine + | |||
| 80 mM | ||||
| glutamic | ||||
| acid | ||||
| 10 mM glutamate, | 130 mM | 15.88 | 5.76 | hazy |
| pH 5.5 | proline + | |||
| 70 mM | ||||
| NaCl |
| Formulation | Buffer | Final | Concentration | Viscosity | |||
|---|---|---|---|---|---|---|---|
| Formulation | components | Excipient | Buffer | pH | pH | on (mg/mL) | (cP) |
| 1. A48SuT | acetic acid; | Sucrose | Acetate | 3.8 | 5.11 | 148.95 | 12.61 |
| sucrose, and | |||||||
| polysorbate | |||||||
| 20 | |||||||
| 2. E44GT | Glutamic | Glycine | L-glutamic | 3.2 | 3.33 | 148 | 19.60 |
| acid, glycine, | acid | ||||||
| and | |||||||
| polysorbate | |||||||
| 20 | |||||||
| 3. A48GT | acetic acid, | Glycine | Acetate | 3.8 | 4.64 | 150.3 | 7.64 |
| glycine, and | |||||||
| polysorbate | |||||||
| 20 | |||||||
| 4. E40/48GT | glutamic | Glycine | L-glutamic | 4 | 4.72 | 153.84 | 6.95 |
| acid, glycine, | acid | ||||||
| polysorbate | |||||||
| 20 | |||||||
| 5. E52GT | glutamic | Glycine | L-glutamic | 4.2 | 4.85 | 147.99 | 6.51 |
| acid, glycine, | acid | ||||||
| polysorbate | |||||||
| 20 | |||||||
| 6. E48PT | glutamic | Proline | L-glutamic | 3.8 | 4.55 | 147.3 | 5.99 |
| acid, proline, | acid | ||||||
| and | |||||||
| polysorbate | |||||||
| 20 | |||||||
| 7. E52PT | glutamic | Proline | L-glutamic | 4.2 | 4.93 | 147.88 | 6.69 |
| acid, proline, | acid | ||||||
| and | |||||||
| polysorbate | |||||||
| 20 | |||||||
| 8. E48ST | glutamic | Sorbitol | L-glutamic | 3.8 | 4.79 | 148.7 | 7.55 |
| acid, sorbitol, | acid | ||||||
| and | |||||||
| polysorbate | |||||||
| 20 | |||||||
| 9. E44SuT | glutamic | Sucrose | L-glutamic | 3.2 | 4.66 | 148.55 | 7.61 |
| acid, | acid | ||||||
| sucrose, and | |||||||
| polysorbate | |||||||
| 20 | |||||||
| 10. E48SuT | glutamic | Sucrose | L-glutamic | 3.8 | 4.85 | 147.36 | 8.42 |
| acid, | acid | ||||||
| sucrose, and | |||||||
| polysorbate | |||||||
| 20 | |||||||
| 11. A48PT | acetic acid, | Proline | Acetate | 4.8 | 153.57 | 6.89 | |
| proline, and | |||||||
| polysorbate | |||||||
| 20 |
| (mg/ml) | Density | mPa*s |
|---|---|---|
| 47.725 | 1.027807 | 1.5842 |
| 72.086 | 1.034805 | 2.2012 |
| 91.429 | 1.042012 | 3.4675 |
| 127.04 | 1.052502 | 9.3879 |
| 130.37 | 1.054458 | 12.1759 |
| 163.22 | 1.061677 | 27.9541 |
| Sample | time 0 | 1 month | 3 month | SEC % MP | |
|---|---|---|---|---|---|
| 1 | A48SuT | 99.65 | 99.66 | 99.63 | 0.02 |
| 2 | E44GT | 45.63 | 40.96 | 41.65 | 3.98 |
| 3 | A48GT | 99.7 | 99.67 | 99.67 | 0.03 |
| 4 | E4048GT | 99.76 | 99.72 | 99.68 | 0.08 |
| 5 | E52GT | 99.7 | 99.7 | 99.68 | 0.02 |
| 6 | E48PT | 99.75 | 99.73 | 99.7 | 0.05 |
| 7 | E52PT | 99.71 | 99.71 | 99.7 | 0.01 |
| 8 | E48ST | 99.67 | 99.69 | 99.46 | 0.21 |
| 9 | E44SuT | 99.73 | 99.69 | 99.72 | 0.01 |
| 10 | E48SuT | 99.57 | 99.61 | 99.62 | −0.05 |
| Sample | 0 | 1 m | 3 m | Decrease in SE % MP | |
|---|---|---|---|---|---|
| 1 | A48SuT | 99.65 | 99.44 | 99.23 | 0.42 |
| 2 | E44GT | 45.63 | 2.6 | 1.76 | 43.87 |
| 3 | A48GT | 99.7 | 99.5 | 99.09 | 0.61 |
| 4 | E4048GT | 99.76 | 99.53 | 99.13 | 0.63 |
| 5 | E52GT | 99.7 | 99.58 | 99.23 | 0.47 |
| 6 | E48PT | 99.75 | 99.64 | 99.42 | 0.33 |
| 7 | E52PT | 99.71 | 99.63 | 99.45 | 0.26 |
| 8 | E48ST | 99.67 | 99.56 | 99.33 | 0.34 |
| 9 | E44SuT | 99.73 | 99.56 | 99.33 | 0.4 |
| 10 | E48SuT | 99.57 | 99.44 | 99.15 | 0.42 |
| Dose | t max | C 0 or C max | AUC 0-t | AUC 0-inf | Cl or Cl/F | V z or V z /F | MRT 0-inf |
|---|---|---|---|---|---|---|---|
| (mg/kg) | (hr) | (μg/mL) | (hr · μg/mL) | (hr · μg/mL) | (mL/hr) | (mL) | (hr) |
| (n = 3 per group) | |||||||
| 0.5 IV | — | 9.79 | 160 | 168 | 8.33 | 142 | 18 |
| (0.964) | (44.2) | (46) | (2.64) | (14.0) | (3.5) | ||
| 0.5 SC | 27 | 1.28 | 69.7 | 74.2 | 22.2 | 681 | 45 |
| (0.808) | (43.4) | (41) | (11.2) | (522) | (9.5) | ||
| 5 SC | 72 | 20.7 | 3110 | 3120 | 4.70 | 98.7 | 110 |
| (4.82) | (1160) | (1160) | (1.61) | (6.99) | (8.1) | ||
| 50 IV | — | 673 | 56600 | 57000 | 2.33 | 75.2 | 140 |
| (66.5) | (18100) | (18600) | (0.592) | (23.6) | (47) | ||
| 50 SC | 72 | 166 | 33700 | 33700 | 3.98 | 72.2 | 150 |
| (33.4) | (10400) | (10400) | (1.18) | (9.15) | (28) | ||
| Parameters are presented as average (standard deviation [SD]) to 3 significant figures, except for t max and MRT 0-inf | |||||||
| t max = time of C max after subcutaneous (SC) administration; | |||||||
| C max = maximum observed serum concentration; | |||||||
| C 0 = estimated initial concentration after intravenous (IV) bolus administration; | |||||||
| AUC 0-t = area under the concentration-time curve from time 0 to the last quantifiable concentration; | |||||||
| AUC 0-inf = AUC from time 0 to infinity; | |||||||
| CL or CL/F = clearance, calculated as Dose/AUC (0-inf) , | |||||||
| V z or V z /F = apparent volume of distribution based on the terminal phase; |
| No. on | No. on | Subject | ||||
| Part | Cohort | Dose/Route | AM-14 | Placebo | Description | |
| A | 1 | 7 | mg SC | 6 | 2 | Healthy |
| volunteer | ||||||
| A | 2 | 21 | mg SC | 6 | 2 | Healthy |
| volunteer | ||||||
| A | 3 | 21 | mg IV | 3 | 1 | Healthy |
| volunteer | ||||||
| A | 4 | 70 | mg SC | 6 | 2 | Healthy |
| volunteer | ||||||
| A | 5 | 210 | mg SC | 6 | 2 | Healthy |
| volunteer | ||||||
| A | 6 | 210 | mg IV | 4 a | 1 | Healthy |
| volunteer | ||||||
| A | 7 | 420 | mg SC | 6 | 2 | Healthy |
| volunteer | ||||||
| A | 8 | 700 | mg IV | 6 | 2 | Healthy |
| volunteer | ||||||
| B | 9 | 700 | mg IV | 8 | 2 | Moderate to |
| severe | ||||||
| psoriasis | ||||||
| B | 10 | 140 | mg SC | 4 | 1 | Moderate to |
| severe | ||||||
| psoriasis | ||||||
| B | 11 | 350 | mg SC | 8 | 2 | Moderate to |
| severe | ||||||
| psoriasis | ||||||
| IV = intravenous; SC = subcutaneous |
| PASI score | A | B | C-PBO | D | E | F | G | H-PBO | I | J |
|---|---|---|---|---|---|---|---|---|---|---|
| Pre dose | 17.4 | 15.2 | 26.2 | 11.6 | 11.0 | 16.0 | 12.6 | 11.8 | 12.5 | 12.1 |
| Day 15 | 6.6 | 6.1 | 17.8 | 5.2 | 6.4 | 7.8 | 5.0 | 8.4 | 2.7 | 2.9 |
| Day 29 | 4.9 | 2.8 | 17.0 | 4.1 | 5.2 | 4.8 | 2.4 | 9.5 | 2.1 | 0.4 |
| Day 43 | 4.1 | 0.9 | 19.5 | 1.3 | 2.4 | 4.5 | 1.0 | 8.8 | 2.8 | 0.0 |
| Day 64 | 7.0 | 4.5 | 21.2 | 2.2 | 1.8 | 9.5 | 2.4 | 11.4 | 2.8 | 0.0 |
| Day 85 | 7.6 | 5.1 | 18.0 | 3.7 | 4.7 | 14.3 | 8.2 | 12.9 | 10.8 | 0.0 |
| %PASI | ||||||||||
| Reduction | A | B | C-PBO | D | E | F | G | H-PBO | I | J |
| Day 15 | 62% | 60% | 32% | 55% | 42% | 51% | 60% | 29% | 78% | 76% |
| Day 29 | 72% | 82% | 35% | 65% | 53% | 70% | 81% | 19% | 83% | 97% |
| Day 43 | 76% | 94% | 26% | 89% | 78% | 72% | 92% | 25% | 78% | 100% |
| Day 64 | 60% | 70% | 19% | 81% | 84% | 41% | 81% | 3% | 78% | 100% |
| Day 85 | 56% | 66% | 31% | 68% | 57% | 11% | 35% | −9% | 14% | 100% |
| PASI | Placebo | mg dose (IV) | |
|---|---|---|---|
| Response | Time Point | n/N (%) | n/N (%) |
| ≥50% | Day 15 | 0/2(0) | 7/8(88) |
| Day 29 | 0/2(0) | 8/8(100) | |
| Day 43 | 0/2(0) | 8/8(100) | |
| Day 64 | 0/2(0) | 7/8(88) | |
| Day 85 | 0/2(0) | 4/8(50) | |
| ≥75% | Day 15 | 0/2(0) | 2/8(25) |
| Day 29 | 0/2(0) | 5/8(63) | |
| Day 43 | 0/2(0) | 7/8(88) | |
| Day 64 | 0/2(0) | 4/8(50) | |
| Day 85 | 0/2(0) | 1/8(13) | |
| ≥90% | Day 15 | 0/2(0) | 0/8(0) |
| Day 29 | 0/2(0) | 1/8(13) | |
| Day 43 | 0/2(0) | 3/8(38) | |
| Day 64 | 0/2(0) | 1/8(13) | |
| Day 85 | 0/2(0) | 1/8(13) | |
| N = Number of subjects who received treatment and had an assessment at each visit | |||
| n = Number of responders at each visit |
| A | B | C | D | E-PBO | |
|---|---|---|---|---|---|
| Cohort 10 | |||||
| PASI score | |||||
| Pre dose | 12.6 | 15.4 | 10.5 | 11.0 | 16.8 |
| Day 15 | 12.0 | 11.6 | 5.2 | 8.1 | 17.2 |
| Day 29 | 11.6 | 5.4 | 6.6 | 9.9 | 16.2 |
| Day 43 | 12.1 | 9.8 | 8.1 | 9.8 | 14.8 |
| Day 64 | 15.6 | 13.6 | 8.9 | 10.1 | 15.9 |
| Day 85 | 12.5 | 15.6 | 8.9 | 9.6 | 16.5 |
| % PASI | |||||
| Reduction | |||||
| Day 15 | 5% | 25% | 50% | 26% | −2% |
| Day 29 | 8% | 65% | 37% | 10% | 4% |
| Day 43 | 4% | 36% | 23% | 11% | 12% |
| Day 64 | −24% | 12% | 15% | 8% | 5% |
| Day 85 | 1% | −1% | 15% | 13% | 2% |
| 69671 | 69672 | 69673 | |||
| 68458 | Cohort | Cohort | Cohort | ||
| External | 9 Pre | 9 Pre | 9 Pre | ||
| PsO NL | NL vs. | NL vs. | NL vs. | ||
| Primary | vs. PsO | Cohort | Cohort | Cohort | |
| Sequence | Sequence | L | 9 Pre L | 9 D 15 | 9 D 43 |
| Name | Code | Fold-Change | |||
| CXCL13 | 205242_at | 9.3 | 20.9 | 6.6 | 6.5 |
| GZMB | 210164_at | 3.7 | 7.8 | 2.6 | 1.6 |
| IFNG | 210354_at | 6.3 | 8.5 | 2.5 | 3.0 |
| IL12B | 207901_at | 10.0 | 4.3 | 0.8 | 1.0 |
| IL17A | 216876_s_at | 5.0 | 9.3 | 1.8 | 0.8 |
| IL17F | 234408_at | 3.2 | 3.4 | 0.9 | 1.0 |
| IL19 | 220745_at | 3.6 | 33.9 | 1.1 | 1.2 |
| IL1B | 39402_at | 6.5 | 24.0 | 1.4 | 0.9 |
| IL20 | 224071_at | 4.4 | 12.9 | 1.5 | 1.4 |
| IL22 | 222974_at | 3.1 | 10.7 | 1.6 | 1.0 |
| IL23A | 220054_at | 2.2 | 2.7 | 1.0 | 1.0 |
| IL8 | 202859_x_at | 3.9 | 58.9 | 1.1 | 0.7 |
| KRT16 | 209800_at | 4.4 | 6.5 | 1.0 | 1.5 |
| KRT6A | 209125_at | 2.8 | 3.3 | 1.1 | 1.2 |
| MMP12 | 204580_at | 5.8 | 4.3 | 0.6 | 0.9 |
| MX1 | 202086_at | 3.6 | 3.5 | 1.9 | 1.5 |
| NOS2 | 210037_s_at | 3.2 | 4.6 | 0.9 | 1.3 |
| S100A7A | 232170_at | 11.0 | 33.1 | 0.9 | 1.2 |
| S100A8 | 202917_s_at | 2.8 | 4.3 | 2.3 | 2.1 |
| S100A9 | 203535_at | 6.2 | 14.1 | 1.3 | 1.6 |
| SERPINB13 | 216258_s_at | 3.8 | 24.5 | 1.7 | 3.0 |
| SERPINB3 | 210413_x_at | 11.5 | 55.0 | 1.7 | 2.3 |
| SERPINB4 | 211906_s_at | 16.2 | 91.2 | 1.1 | 1.3 |
| TNF | 207113_s_at | 1.5 | 1.5 | 1.0 | 0.9 |
| Average | 5.6 | 18.5 | 1.6 | 1.6 | |
| PsO = psoriasis; NL = non-lesional; L = lesional; Pre = predose |
| 49933 | 49939 | 68458 | 69671 | 69672 | 69673 | ||
| Experiment Name | |||||||
| 20060279 | |||||||
| Predose | |||||||
| Non- | 20060279 | 20060279 | |||||
| Neg | lesional | Predose | Predose | ||||
| Neg | Control | PsO NL | vs. | Non- | Non- | ||
| Primary | Control vs. | vs. | vs. PsO | PreDose | lesional | lesional | |
| Sequence | Sequence | IL-17A | IFNg | L | Lesional | vs. D15 | vs. D43 |
| Name | Code | Fold-Change | |||||
| C15or148 | 223484_at | 4.7 | 5.5 | 2.5 | 3.8 | 0.6 | 0.8 |
| CCL20 | 205476_at | 4.2 | 0.9 | 5.8 | 28.8 | 1.7 | 1.4 |
| CXCL1 | 204470_at | 3.4 | 1.7 | 4.4 | 38.9 | 4.6 | 4.1 |
| CXCL6 | 206336_at | 6.0 | 0.5 | 4.2 | 17.8 | 1.5 | 1.2 |
| DEFB4 | 207356_at | 45.7 | 5.4 | 8.9 | 33.1 | 0.6 | 0.8 |
| IL1F9 | 220322_at | 5.4 | 2.8 | 4.9 | 22.9 | 1.6 | 2.9 |
| LCN2 | 212531_at | 3.7 | 0.5 | 8.5 | 13.8 | 3.8 | 4.2 |
| PDZK1IP1 | 219630_at | 10.2 | 11.5 | 2.6 | 6.0 | 1.0 | 1.6 |
| PDZK1IP1 | 1553589_a_at | 9.8 | 10.7 | 2.6 | 7.1 | 1.1 | 1.4 |
| RHCG | 219554_at | 2.8 | 1.2 | 4.6 | 11.2 | 0.6 | 0.7 |
| S100A12 | 205863_at | 4.1 | 2.1 | 14.1 | 95.5 | 1.7 | 0.3 |
| S100A7 | 205916_at | 6.8 | 2.1 | 1.9 | 2.9 | 1.3 | 1.4 |
| SAA1 | 208607_s_at | 4.3 | 3.7 | 1.6 | 3.7 | 3.5 | 4.9 |
| SAA1 | 214456_x_at | 2.9 | 2.8 | 2.0 | 3.6 | 4.0 | 3.7 |
| SPRR2C | 220664_at | 5.9 | 0.9 | 10.5 | 32.4 | 0.5 | 0.5 |
| TMPRSS11D | 207602_at | 7.8 | 6.3 | 4.1 | 89.1 | 2.3 | 0.8 |
| VNN3 | 220528_at | 83.2 | 11.0 | 8.9 | 100.0 | 2.9 | 1.7 |
| ZC3H12A | 218810_at | 3.2 | 1.8 | 3.0 | 4.7 | 1.7 | 1.4 |
| Average | 11.9 | 4.0 | 5.3 | 28.6 | 1.9 | 1.9 |
| 49933.0 | 49939.0 | 68458.0 | 69671.0 | 69672.0 | 69673.0 | ||
| Experiment Name | |||||||
| 20060279 | |||||||
| Predose | 20060279 | ||||||
| Neg | Neg | Non- | 20060279 | Predose | |||
| Control | Control | lesional vs. | Predose | Non- | |||
| Primary | vs. | vs. | PsO NL | PreOose | Non-lesional | lesional vs. | |
| Sequence | Sequence | IL-17A | IFNg | vs. PsO L | Lesional | vs. 015 | 043 |
| Name | Code | Fold-Change | |||||
| 1570541_s_at | 1570541_s_at | 1.0 | 100.0 | 5.5 | 6.5 | 2.1 | 1.9 |
| 239979_at | 239979_at | 0.8 | 17.0 | 4.2 | 3.3 | 2.4 | 2.2 |
| ACE2 | 219962_at | 1.0 | 31.6 | 4.9 | 8.5 | 1.5 | 1.6 |
| AIM2 | 206513_at | 0.8 | 100.0 | 5.5 | 4.3 | 1.9 | 1.7 |
| APOL1 | 209546_s_at | 0.9 | 63.1 | 2.7 | 2.6 | 1.3 | 1.1 |
| APOL6 | 219716_at | 0.9 | 17.8 | 3.3 | 2.7 | 1.1 | 0.8 |
| APOL6 | 241869_at | 0.7 | 41.7 | 4.1 | 1.9 | 1.1 | 1.0 |
| CCL22 | 207861_at | 0.9 | 22.4 | 3.5 | 3.5 | 0.9 | 1.2 |
| CCL5 | 1405_i_at | 0.2 | 22.4 | 1.5 | 1.4 | 2.2 | 2.1 |
| CCL5 | 204655_at | 0.3 | 20.0 | 1.4 | 1.3 | 2.3 | 1.8 |
| CCL7 | 208075_s_at | 0.5 | 89.1 | 3.8 | 5.4 | 1.6 | 1.0 |
| CCL8 | 214038_at | 0.8 | 100.0 | 1.7 | 1.8 | 1.3 | 1.0 |
| CLEC7A | 221698_s_at | 0.9 | 21.4 | 2.8 | 3.6 | 1.9 | 1.7 |
| EBI3 | 219424_at | 0.4 | 21.4 | 3.6 | 3.1 | 1.3 | 1.1 |
| GBP4 | 235175_at | 1.0 | 100.0 | 1.8 | 1.2 | 1.3 | 1.1 |
| GBP5 | 238581_at | 0.8 | 100.0 | 6.6 | 4.6 | 3.1 | 2.1 |
| GBP5 | 229625_at | 0.8 | 91.2 | 3.0 | 3.3 | 2.6 | 2.2 |
| IFIT3 | 204747_at | 0.9 | 21.4 | 2.9 | 3.0 | 1.1 | 1.3 |
| IL12RB1 | 1552584_at | 0.6 | 61.7 | 2.0 | 2.3 | 1.7 | 1.6 |
| IL2RG | 204116_at | 0.6 | 67.6 | 2.0 | 2.0 | 1.3 | 1.5 |
| IL32 | 203828_s_at | 0.5 | 19.5 | 2.1 | 1.4 | 1.5 | 1.8 |
| IRF1 | 238725_at | 0.8 | 83.2 | 1.9 | 1.3 | 1.0 | 0.9 |
| ISG20 | 33304_at | 1.0 | 53.7 | 3.2 | 3.2 | 1.3 | 1.3 |
| ISG20 | 204698_at | 1.2 | 45.7 | 2.9 | 2.8 | 1.3 | 1.1 |
| LIPA | 236156_at | 0.7 | 27.5 | 2.9 | 2.3 | 1.4 | 1.0 |
| RSAD2 | 213797_at | 1.1 | 46.8 | 6.0 | 9.8 | 2.5 | 1.6 |
| RSAD2 | 242625_at | 1.1 | 52.5 | 4.5 | 3.9 | 1.3 | 1.1 |
| RTP4 | 219684_at | 0.6 | 100.0 | 4.3 | 6.0 | 3.2 | 1.9 |
| SAMD9L | 226603_at | 0.8 | 19.1 | 1.7 | 1.5 | 1.4 | 1.3 |
| SLC15A3 | 219593_at | 1.0 | 100.0 | 1.3 | 1.0 | 1.0 | 1.0 |
| TNFRSF9 | 211786_at | 0.6 | 14.1 | 3.1 | 3.3 | 2.1 | 1.5 |
| TRIM10 | 221627_at | 0.7 | 21.4 | 4.2 | 13.8 | 3.6 | 3.6 |
| XAF1 | 206133_at | 0.9 | 16.6 | 2.3 | 1.8 | 1.6 | 1.2 |
| Average | 0.8 | 51.7 | 3.1 | 3.4 | 1.7 | 1.5 |
| IFN-gamma | IL17A | |
|---|---|---|
| Distance | Distance | |
| NonLesional PreDose | 674 | 10403 |
| Lesional PreDose | 8465 | 627631 |
| Lesional Day 15 | 2338 | 4133 |
| Lesional Day 43 | 1705 | 1329 |
| NonLesional External | 712 | 82285 |
| Lesional External | 11122 | 649648 |
| Subject | NL | LS d 0 | LS d 14 | LS d 42 |
|---|---|---|---|---|
| CD3+ | ||||
| AM-14A | 92 | 305 | 258 | 149 |
| AM-14 B | 171 | 139 | 144 | 83 |
| PBO A | 8 | 155 | 508 | 247 |
| AM-14 C | 27 | 368 | 253 | 105 |
| AM-14 D | 50 | 507 | 0 | 176 |
| PBO B | 37 | 295 | 338 | 374 |
| AM-14 E | NA | 600 | 284 | 201 |
| AM-14 F | 57 | 143 | 153 | 168 |
| AM-14 G | 54 | 248 | 244 | 88 |
| AM-14 H | 46 | 177 | 102 | 54 |
| mean | 71 | 311 | 180 | 128 |
| sd | 48 | 171 | 98 | 53 |
| CD11c+ | ||||
| AM-14 A | 189 | 478 | 336 | 168 |
| AM-14 B | 57 | 205 | 124 | 167 |
| PBO A | 30 | 141 | 264 | 298 |
| AM-14 C | 85 | 322 | 696 | 85 |
| AM-14 D | 72 | 463 | 235 | 228 |
| PBO B | 77 | 192 | 488 | 985 |
| AM-14 E | 358 | 156 | 156 | |
| AM-14 F | 108 | 987 | 318 | 150 |
| AM-14 G | 42 | 128 | 93 | 78 |
| AM-14 H | 79 | 204 | 285 | 109 |
| mean | 90 | 393 | 280 | 143 |
| sd | 48 | 271 | 191 | 50 |
| CD8+ | ||||
| AM-14 A | ||||
| AM-14 B | 35 | 103 | 61 | 19 |
| PBO A | 11 | 64 | 92 | 43 |
| AM-14 C | 56 | 56 | 150 | 39 |
| AM-14 D | 26 | 118 | 165 | 89 |
| PBO B | 7 | 30 | 60 | 172 |
| AM-14 E | 231 | 67 | 46 | |
| AM-14 F | 6 | 284 | 55 | 106 |
| AM-14 G | 47 | 28 | 64 | 48 |
| AM-14 H | 72 | 132 | 63 | 48 |
| mean | 40 | 136 | 89 | 56 |
| sd | 23 | 92 | 47 | 30 |
| DC-LAMP | ||||
| AM-14 A | ||||
| AM-14 B | 10 | 48 | 19 | 11 |
| PBO A | 0 | 92 | 60 | 59 |
| AM-14 C | 5 | 67 | 148 | 8 |
| AM-14 D | 0 | 32 | 15 | 45 |
| PBO B | 0 | 98 | 142 | 250 |
| AM-14 E | 267 | 5 | 2 | |
| AM-14 F | 0 | 150 | 28 | 14 |
| AM-14 G | 0 | 42 | 6 | 4 |
| AM-14 H | 0 | 56 | 3 | 0 |
| mean | 3 | 95 | 32 | 12 |
| sd | 4 | 86 | 52 | 15 |
| Treatments | Interval | ||||
| Compared | Difference | Coverage | Lower | Upper | p-value |
| A vs F | −42.3 | 90 | −48.0 | −36.6 | <0.0001 |
| B vs F | −44.8 | 95 | −51.6 | −38.0 | <0.0001 |
| C vs F | −28.4 | 95 | −35.3 | −21.6 | <0.0001 |
| D vs F | −36.0 | 95 | −42.8 | −29.2 | <0.0001 |
| E vs F | −32.6 | 95 | −39.5 | −25.8 | <0.0001 |
| A vs B | 2.5 | 90 | −3.2 | 8.2 | 0.4700 |
| A vs D | −6.3 | 90 | −12.0 | −0.6 | 0.0711 |
| B vs D | −8.8 | 95 | −15.6 | −2.0 | 0.0117 |
| B vs C | −16.4 | 95 | −23.2 | −9.5 | <0.0001 |
| B vs E | −12.2 | 95 | −19.0 | −5.3 | 0.0005 |
| AM-14 | AM-14 | AM-14 | AM-14 | ||
|---|---|---|---|---|---|
| 70 mg | 140 mg | 210 mg | 280 mg | ||
| Placebo | q2W | q2W | q2W | q4W | |
| (N = 38) | (N = 39) | (N = 39) | (N = 40) | (N = 42) | |
| n/N1 (%) | n/N1 (%) | n/N1 (%) | n/N1 (%) | n/N1 (%) | |
| PASI 75 | 0/38 | 13/39 | 30/39 | 33/40 | 28/42 |
| Response | (0.0%) | (33.3%) | (76.9%) | (82.5%) | (66.7%) |
| P value | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |
| PASI 90 | 0/38 | 7/39 | 28/39 | 30/40 | 24/42 |
| Response | (0.0%) | (17.9%) | (71.8%) | (75.0%) | (57.1%) |
| P value | 0.0057 | <0.0001 | <0.0001 | <0.0001 | |
| PASI 100 | 0/38 | 4/39 | 15/39 | 25/40 | 12/42 |
| Response | (0.0%) | (10.3%) | (38.5%) | (62.5%) | (28.6%) |
| P value | 0.0452 | <0.0001 | <0.0001 | 0.0003 | |
| N = Number of participants randomized | |||||
| n = Number of responders | |||||
| N1 = Number of participants who were randomized and had a valid measurement value at week 12, after imputation % = n/N1*100 | |||||
| P value is for comparison between each AM-14 dose group and placebo and is nominal without multiplicity adjustment | |||||
| P value was based on the Cochran-Mantel-Haenszel Test stratified by BMI (Body Mass Index) group (≤35, >35) and adjusted for baseline PASI group (≤median (17.45), >median (17.49)) | |||||
| NRI (NonResponder Imputation) was used to impute missing data |
Claims
6 · 1 independent · depth 2Classifications
3 codes- A61K39/00
- A61K39/395
- C07K16/28
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2 priority documents›Priority documents — 2
| Type | Document | Date |
|---|---|---|
| provisional | US 61422059 | 10 Dec 2010 |
| related publication | US 20200399384 A1 | 24 Dec 2020 |
Worldwide family
78 members · 38 offices›IP5 & PCT — 24 members
| Office | Publication | Kind | Published | Filed | Status | Title |
|---|---|---|---|---|---|---|
| US | US-2013022621-A1 | A1 | 24 Jan 2013 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| US | US-8883151-B2 | B2 | 11 Nov 2014 | 12 Jan 2011 | granted | IL-17 receptor antibody formulation |
| US | US-2015017184-A1 | A1 | 15 Jan 2015 | 29 Sep 2014 | published | IL-17 Receptor Antibody Formulation |
| US | US-10072085-B2 | B2 | 11 Sep 2018 | 29 Sep 2014 | granted | Method of treating psoriasis using an IL-17 receptor antibody formulation |
| US | US-2018346583-A1 | A1 | 6 Dec 2018 | 2 Aug 2018 | published | Method of treating psoriasis using an il-17 receptor antibody formulation |
| US | US-10808033-B2 | B2 | 20 Oct 2020 | 2 Aug 2018 | granted | IL-17 receptor antibody formulation |
| US | US-2020399384-A1 | A1 | 24 Dec 2020 | 8 Sep 2020 | published | Method of treating diseases using an il-17 receptor antibody formulation |
| USthis patent | US-11505612-B2 | B2 | 22 Nov 2022 | 8 Sep 2020 | granted | Method of treating diseases using an IL-17 receptor antibody formulation |
| US | US-2023192873-A1 | A1 | 22 Jun 2023 | 11 Oct 2022 | published | Method of treating diseases using an il-17 receptor antibody formulation |
| EP | EP-2523688-A1 | A1 | 21 Nov 2012 | 12 Jan 2011 | published | Antikörperformulierung und therapeutische regimende |
| EP | EP-2523688-B1 | B1 | 11 Oct 2017 | 12 Jan 2011 | granted | Antikörperformulierung und therapeutische regimende |
| EP | EP-3295957-A1 | A1 | 21 Mar 2018 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| EP | EP-3295957-B1 | B1 | 7 Aug 2019 | 12 Jan 2011 | granted | Anti il-17ra-antikörperformulierung und therapeutische regimen zur behandlung von psoriasisde |
| EP | EP-3632466-A1 | A1 | 8 Apr 2020 | 12 Jan 2011 | published | Anti il-17ra antibody formulation and therapeutic regimens for treating psoriasis |
| JP | JP-2013517277-A | A | 16 May 2013 | 12 Jan 2011 | published | 抗体製剤及び治療レジメンja |
| JP | JP-2015052017-A | A | 19 Mar 2015 | 5 Dec 2014 | published | Antibody formulation and therapeutic regimen |
| JP | JP-5743234-B2 | B2 | 1 Jul 2015 | 12 Jan 2011 | granted | 抗体製剤及び治療レジメンja |
| KR | KR-20120118036-A | A | 25 Oct 2012 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| KR | KR-101766936-B1 | B1 | 9 Aug 2017 | 12 Jan 2011 | granted | 항체 제제 및 치료 요법ko |
| CN | CN-102821787-A | A | 12 Dec 2012 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| CN | CN-102821787-B | B | 29 Jul 2015 | 12 Jan 2011 | granted | Antibody preparation and therapeutic scheme |
| WO | WO-2011088120-A1 | A1 | 21 Jul 2011 | 12 Jan 2011 | published | Formulation d'anticorps et régimes thérapeutiquesfr |
| WO | WO-2011088120-A9 | A9 | 9 Aug 2012 | 12 Jan 2011 | published | Formulation d'anticorps et régimes thérapeutiquesfr |
| WO | WO-2011088120-A8 | A8 | 13 Sep 2012 | 12 Jan 2011 | published | Formulation d'anticorps et régimes thérapeutiquesfr |
›Other offices — 54 members
| Office | Publication | Kind | Published | Filed | Status | Title |
|---|---|---|---|---|---|---|
| AR | AR-079903-A1 | A1 | 29 Feb 2012 | 14 Jan 2011 | published | Formulacion de anticuerpo y regimenes terapeuticos. envase farmaceutico. kit.es |
| AU | AU-2011205402-A1 | A1 | 12 Jul 2012 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| AU | AU-2011205402-B2 | B2 | 5 Feb 2015 | 12 Jan 2011 | granted | Antibody formulation and therapeutic regimens |
| AU | AU-2015202023-A1 | A1 | 14 May 2015 | 21 Apr 2015 | published | Antibody formulation and therapeutic regimens |
| AU | AU-2015202023-B2 | B2 | 18 May 2017 | 21 Apr 2015 | granted | Antibody formulation and therapeutic regimens |
| AU | AU-2017216579-A1 | A1 | 7 Sep 2017 | 18 Aug 2017 | published | Antibody formulation and therapeutic regimens |
| BR | BR-112012017150-A2 | A2 | 10 Oct 2017 | 12 Jan 2011 | published | formulação de anticorpo e regimes terapêuticos.pt |
| BR | BR-112012017150-B1 | B1 | 3 Mar 2022 | 12 Jan 2011 | published | Formulação farmacêutica, recipiente farmacêutico, e kitpt |
| CA | CA-2787128-A1 | A1 | 21 Jul 2011 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| CA | CA-2787128-C | C | 11 Jun 2019 | 12 Jan 2011 | granted | Antibody formulation and therapeutic regimens |
| CL | CL-2012001966-A1 | A1 | 18 Jan 2013 | 13 Jul 2012 | published | Formulación farmacéutica que comprende entre 100-150 mg/ml de un anticuerpo que se une específicamente al receptor a de il-17 humana, una solución acuosa de un buffer 5-30 mm de ácido glutámico ph 4,5-5,2, prolina 2-4% p/v y polisorbato-20 0,005-0,02% p/v; envase farmacéutico y kit que comprende dicha formulación; y su uso para tratar psoriasis.es |
| CO | CO-6640206-A2 | A2 | 22 Mar 2013 | 10 Aug 2012 | published | Formulación farmaceútica de una solución acuosa de un bufer de ácido glutámico y un anticuerpoes |
| CR | CR-20120419-A | A | 29 Nov 2012 | 10 Aug 2012 | published | Formulación de anticuerpos y regimenes terapéuticoses |
| CY | CY-1119852-T1 | T1 | 27 Jun 2018 | 9 Jan 2018 | published | Σκευασμα αντισωματος και θεραπευτικα σχηματαel |
| CY | CY-1122466-T1 | T1 | 14 Oct 2020 | 4 Nov 2019 | published | Σκευασμα αντισωματος αντι il-17ra και θεραπευτικα σχηματα για την αγωγη της ψωριασηςel |
| DK | DK-2523688-T3 | T3 | 4 Dec 2017 | 12 Jan 2011 | granted | Antistofformulering og terapeutiske regimenerda |
| DK | DK-3295957-T3 | T3 | 14 Oct 2019 | 12 Jan 2011 | granted | Anti il-17ra-antistofformulering og terapeutiske regimener til behandling af psoriasisda |
| EA | EA-201290653-A1 | A1 | 28 Feb 2013 | 12 Jan 2011 | published | Состав антитела и терапевтические режимыru |
| EA | EA-201891433-A2 | A2 | 30 Nov 2018 | 12 Jan 2011 | published | Состав антитела и терапевтические режимыru |
| EA | EA-031209-B1 | B1 | 28 Dec 2018 | 12 Jan 2011 | published | Antibody pharmaceutical formulation for treating an inflammatory disease and methods of using same |
| EA | EA-201891433-A3 | A3 | 28 Feb 2019 | 12 Jan 2011 | published | Состав антитела и терапевтические режимыru |
| EA | EA-031209-B9 | B9 | 19 Nov 2021 | 12 Jan 2011 | published | Antibody pharmaceutical formulation for treating an inflammatory disease and methods of using same |
| ES | ES-2652637-T3 | T3 | 5 Feb 2018 | 12 Jan 2011 | granted | Formulación de anticuerpos y regímenes terapéuticoses |
| ES | ES-2753216-T3 | T3 | 7 Apr 2020 | 12 Jan 2011 | granted | Formulación de anticuerpos anti-IL17RA y regímenes terapéuticos para el tratamiento de la psoriasises |
| HR | HR-P20171939-T1 | T1 | 23 Mar 2018 | 12 Jan 2011 | published | Formulacija protutijela i režimi terapijehr |
| HU | HU-E035618-T2 | T2 | 28 May 2018 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| HU | HU-E046670-T2 | T2 | 30 Mar 2020 | 12 Jan 2011 | published | Anti IL-17RA ellenanyag kiszerelés és terápiás rendek pikkelysömör kezelésérehu |
| IL | IL-220602-B | B | 31 Mar 2019 | 24 Jun 2012 | published | Antibody formulation and use thereof for the reparation of a pharnaceutical formulation for the treatment of psoriasis |
| IN | IN-2012DN06720-A | A | 23 Oct 2015 | 12 Jan 2011 | published | no title held |
| LT | LT-2523688-T | T | 12 Mar 2018 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| LT | LT-3295957-T | T | 27 Jan 2020 | 12 Jan 2011 | published | Anti il-17ra antibody formulation and therapeutic regimens for treating psoriasis |
| MA | MA-33989-B1 | B1 | 1 Feb 2013 | 12 Jan 2011 | published | Formulation d'anticorps et régimes thérapeutiquesfr |
| MX | MX-2012008213-A | A | 6 Nov 2012 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens. |
| MX | MX-349856-B | B | 16 Aug 2017 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens. |
| MY | MY-182680-A | A | 29 Jan 2021 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| NO | NO-2523688-T3 | T3 | 10 Mar 2018 | 12 Jan 2011 | published | no title held |
| NZ | NZ-601125-A | A | 29 Aug 2014 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| PE | PE-20121691-A1 | A1 | 14 Dec 2012 | 12 Jan 2011 | published | Formulacion de anticuerpos y regimenes terapeuticoses |
| PH | PH-12012501364-A1 | A1 | 22 Oct 2012 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| PL | PL-2523688-T3 | T3 | 30 Apr 2018 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| PL | PL-3295957-T3 | T3 | 31 Mar 2020 | 12 Jan 2011 | published | Anti il-17ra antibody formulation and therapeutic regimens for treating psoriasis |
| PT | PT-2523688-T | T | 5 Jan 2018 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| PT | PT-3295957-T | T | 12 Nov 2019 | 12 Jan 2011 | published | Anti il-17ra antibody formulation and therapeutic regimens for treating psoriasis |
| RS | RS-56781-B1 | B1 | 30 Apr 2018 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| RS | RS-59743-B1 | B1 | 28 Feb 2020 | 12 Jan 2011 | published | Anti il-17ra antibody formulation and therapeutic regimens for treating psoriasis |
| SG | SG-182468-A1 | A1 | 30 Aug 2012 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| SG | SG-10201604093X-A | A | 28 Jul 2016 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| SI | SI-2523688-T1 | T1 | 30 Mar 2018 | 12 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| SI | SI-3295957-T1 | T1 | 28 Feb 2020 | 12 Jan 2011 | published | Anti il-17ra antibody formulation and therapeutic regimens for treating psoriasis |
| TN | TN-2012000335-A1 | A1 | 12 Dec 2013 | 26 Jun 2012 | published | Antibody formulation and therapeutic regimens |
| TW | TW-201129382-A | A | 1 Sep 2011 | 14 Jan 2011 | published | Antibody formulation and therapeutic regimens |
| TW | TW-I554282-B | B | 21 Oct 2016 | 14 Jan 2011 | granted | Antibody formulation and therapeutic regimens |
| UA | UA-112288-C2 | C2 | 25 Aug 2016 | 12 Jan 2011 | published | Antibody forvulation and therapeutic regimens |
| ZA | ZA-201205167-B | B | 27 Mar 2013 | 11 Jul 2012 | published | Antibody formulation and therapeutic regimens |
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